Device Advice by RQM+

This show was recorded 25 May 2023 and can be viewed on our website ⁠⁠here⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠Knowledge Center⁠⁠⁠. Thank you for listening!

This panel discussion is all about navigating off-label use and implementing strategies to improve medical device safety. As we all know, ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers. However, one of the key challenges manufacturers face is how to identify and handle off-label use, especially with the transition to MDR 2017/745.

During the discussion, our experts in device development, regulatory compliance and clinical evaluation shared insights on how to manage off-label use, reduce indications, define indications and contra-indications, as well expand indications using real-world data from post-market surveillance. We dove into the complexities of post-market surveillance and the importance of PMCF data in identifying off-label use. We also explored strategies for optimizing regulatory efforts while maintaining patient safety.

Key questions for our audience include:

Our panelists provided valuable insights into these questions and more from the audience! We hope you'll give this show a listen.

Panelists:

This show was recorded 27 April 2023 and can be viewed on our website ⁠here⁠. The website recording has clickable chapters allowing you to instantly jump to different questions/topics. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠Knowledge Center⁠⁠.

What type of evidence is considered sufficient to comply with the MDR? While we've spoken about this extensively in the past, we'll explore more ways to arrive at the answer and address many more questions this RQM+ Live! show.

Perhaps in certain situations you're asking yourself, "What kind of clinical evidence do I need for my device?"

Our seasoned panelists will share ways to determine exactly that by sharing recent thought processes and examples. We'll set the tone upfront with a list of factors that affect the 'definition' of sufficient clinical data, generally speaking: intended purpose, novelty, benefit-risk profiles, number of indications, users, where it's used in the world and supportive non-clinical data... just to name a few.

What we'll cover:

This will truly be a loaded session that our team is incredibly excited about! There's much to discuss and our goal, as always, is to provide as much actionable value as possible for you.

Panelists:

Today's new installment of MedTech Voices revisits a series from last year on EU MDR Expert Panel Feedback, where Jaishankar Kutty, Ph.D. and Andreas Tarnaris M.D. offer their perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year.
👂 Why should you listen?
📑 Hear what is being submitted to the notified bodies by manufactures
📋 Hear what has been submitted by the notified bodies for expert panel review
🩺 Hear a clinician's perspective on what clinicians on the expert panel are reviewing and commenting on
This third episode focuses on an orthopedic device submitted by a notified body. Previous clips focused on an intro to the series (#1) and a Class III implantable device, which happened to be a bone graft intended for maxillofacial surgeries (#2). We'll link to both of these in the comments.
Thank you for listening!

📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠⁠our contact form⁠⁠.

👩‍⚕️ ⁠Sally Sennitt, M.D. – Medical Director⁠

👨‍⚕️ ⁠Andreas Tarnaris M.D. – Medical Director⁠

👨‍💼 ⁠Jaishankar Kutty, Ph.D. – Vice President of Intelligence and Innovation⁠

For the video version of this episode, please watch on the ⁠RQM+ LinkedIn page⁠ or Spotify.

For information about how RQM+ helps clients in these areas:

➕ ⁠CERs⁠

➕ ⁠PMCF⁠

➕ ⁠PMCF Survey Development and Execution⁠

📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠our contact form⁠.

Our MedTech Voices 10 minutes or less video/audio series, returns with the first of two new clips in a mini series entitled Traversing the Path from CER to PMCF – Clinician Perspective. These two clips will combine clinician and notified body perspectives to share information that will help you avoid errors when approaching your PMCF activities.
Featured experts with LinkedIn profile links:
👩‍⚕️ Sally Sennitt, M.D. – Medical Director
👨‍⚕️ Andreas Tarnaris M.D. – Medical Director
👨‍💼 Jaishankar Kutty, Ph.D. – Vice President of Intelligence and Innovation
For the video version of this episode, please watch on the RQM+ LinkedIn page or Spotify.
For information about how RQM+ helps clients in these areas:
➕ CERs
➕ PMCF
➕ PMCF Survey Development and Execution
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.

This show was recorded 23 March 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠Knowledge Center⁠.

Artificial Intelligence (AI) has the potential to revolutionize healthcare and the medical technology industry, with the ability to assist in clinical decision-making, improve patient outcomes, accelerate speed to market and improve  efficiency. In this RQM+ Live! show, leaders from RQM+ and Giotto.ai will explore the current and future applications of AI in MedTech, including the use of AI in medical imaging, diagnostics, personalized medicine, remote patient monitoring and medical writing. They will also share their insights on the challenges they've experienced so far in the field, and how AI can help solve some of the hardest problems facing the healthcare industry.
 
This session is designed to be educational and conversational, so please come prepared with questions! The goal of this session is to talk openly and generate ideas about how AI can best benefit you and your organization, now and in the future. We predict companies in the MedTech space who successfully harness AI/ML will have a significant advantage over those that do not.

Panelists:

Questions with timestamps:

3:07 -- Framing the conversation with definitions... what do these terms mean and how do they differ from automation?

6:50 -- Could you provide examples of how this technology is being used more broadly in life sciences today?

8:40 -- What about from a more specific MedTech perspective?

9:20 -- What about from the industry perspective in general?

10:18 -- How does the transparency and explainability of AI effect its adoption? How can we trust AI?

13:43 -- In a healthcare setting, how are regulators responding to this increased adoption of AI / ML?

14:40 -- If AI is based on pattern recognition, is it possible that when a large amount of misinformation is fed into the algorithm that it causes the AI to make a poor decision? How do you work to prevent this?

16:41 -- What could manufacturers do to leverage AI / ML in their workflows? For example, where do they have large pools of data that could lend itself to using AI / ML to improve the workflows of internal operations or compliance itself?

19:15 -- Once we're thinking about the implementation stage, what are some of the challenges that a manufacturer will encounter along this journey?

23:10 -- What advice would you give a manufacturer in how to approach regulators with a new AI device? Also, do regulators have the necessary expertise from a review perspective?

26:57 -- Regarding data sets, if manufacturers are leveraging consultants or IT groups, how can they work to be sure the data set models are maintainable?

30:57 -- What are you thoughts about AI taking over roles?

36:05 -- How would you avoid bias when using ML and that data?

41:29 -- How would you recommend the listeners get started?

This is audio from RQM+ Live! #64, recorded 16 February 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

Over the past several years the expectations for testing of medical devices per the ISO 10993 standards has significantly changed and continues to change at a rapid pace. Furthermore, different regulatory bodies have different expectations when evaluating this data. Failure to understand these expectations and an inappropriate choice of testing labs can result in product delays and repeat testing.

The expert panel will:

Panelists:

This is audio from RQM+ Live! #63, recorded 26 January 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

The MedTech industry is one of the most heavily regulated industries in the world. The regulatory landscape is changing rapidly and regulations are increasingly more complex.

An efficient and scalable regulatory strategy is now more important than ever. As regulatory bodies worldwide update and enforce regulations at an accelerated pace, the need for speed and flexibility in regulatory functions has never been more critical. The alternatives are failed and damaging regulatory submissions that could ultimately stop a product from coming to market.

In this RQM Live! show, our panelists bring their unique perspectives on the world's largest regulatory markets, the US FDA and EU MDR/IVDR.

Our subject matter experts will:

Panelists:

Questions with timestamps:

4:22 -- So much has changed over the past few years. Let's discuss how much of a jump it's been for the European market compared to a few years ago and what that means for the FDA side?

9:40 -- What are the top five things that manufacturers underestimate about these regulatory requirements?

10:34 -- How do you go about gathering and presenting documentation for an MDR compliant submission when your notified body won't communicate their criteria and refuses to offer guidance because they're not consultants?

24:20 -- Considering the differences between the EU and the US, what about some of the synergies between the two?

33:18 -- What updates or advice do you have on the timeline extension on the MDR and IVDR?

37:05 -- Are they extending the MDD certifications?

41:48 -- If our MDD certificate expiries in March 2024, wouldn't it need a new date at that point to sell from that day until the MDR certification is obtained? It could take two years until that point...

45:40 -- In relation to the MDD/MDR transition period, for elements like standards, where there may be a difference between the MDD harmonized version and the MDR harmonized version, how should manufacturers handle compliance to older versions for MDD when we are trying to transition to the State of the Art harmonized versions for MDR.

49:02 -- There seems to be a strong incentive to not be novel. Do you see companies underplaying novelty and is there a risk to this?

53:21 -- The end of life of our device that is no longer manufactured is planned for 2027 or 2028. Do we have to pursue MDR certification?

54:55 -- What is your experience with the use of off-label data (while supporting the safety and performance of a medical device) for CE-mark?

🔑 1. Focused on notified body feedback and key learnings (find the podcast episode or watch on LinkedIn)
📝 2. Sufficient quality and quantity of clinical evidence (find the podcast episode or watch on LinkedIn)
👣 3. Path from CER to PMCF plan (regulatory perspective)
⚕️ 4. Path from CER to PMCF plan (with medical directors)
🔎 5.+ Deep dive into PMCF plans and outcomes on a per device basis

For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.

For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center. We have a ton of fantastic on-demand content available.

Thank you for listening! We hope you enjoy.

🔑 1. Focused on notified body feedback and key learnings (find the podcast episode or watch on LinkedIn)
📝 2. Sufficient quality and quantity of clinical evidence (this one!)
👣 3. Path from CER to PMCF plan (regulatory perspective) (already recorded and coming next week)
⚕️ 4. Path from CER to PMCF plan (with medical directors)
🔎 5.+ Deep dive into PMCF plans and outcomes on a per device basis

For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.

For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center. We have a ton of fantastic on-demand content available.

Thank you for listening! We hope you enjoy.

For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.

For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center here.

Thank you for listening!

For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.

For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center. We have a ton of fantastic on-demand content available.

Thank you for listening! We hope you enjoy.

For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.

For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center here.

Thank you for listening!

For non-Spotify users interested in the video version of this episode, you can view on the RQM+ LinkedIn page here.

Thank you for listening! See more content like this in the Knowledge Center at RQMplus.com.

For non-Spotify users interested in the video version of this episode, you can view on the RQM+ LinkedIn page here.

Thank you for listening! See more content like this in the Knowledge Center at RQMplus.com.

This is audio from RQM+ Live! #62, recorded 3 November, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

Most of us have used standards in some shape or form. There are those that assume they know all about standards, and those who think, “Ugh, standards are so boring.” Yet, how many people actually love standards? How many people always ask, “Is there a standard for this?” We do at RQM+.

The consideration and application of standards is a foundational element across the majority of MedTech product lifecycle activities and can provide a clear route to compliance when used well.

Our panelists will discuss key elements of implementing standards and shine light on dark and often misunderstood corners of the world of standards.

Elements discussed include:

Panelists:

Questions with timestamps:

3:42 -- Brief introduction and what do we mean by State of the Art?

12:25 -- How do you establish State of the Art? Should we not create a State of the Art generic standard that recommends companies look elsewhere for State of the Art? Standards, common specifications, trends, etc.

16:37 -- How do you establish what expected outcomes, performance, or design specifications for a product?

21:04 -- Standard of care can usually lag behind technology and practical clinical development. For example, NICE guidelines defines success in hip replacements as a revision rate of 5% or less at 10 years, however, the best prosthesis usually have revision rates of 1-2% at the same stage. Shouldn't state of the art be defined in this case as the gold standard rather than pull towards the average?

29:55 -- When you say stratify by patient population what are the variables we should stratify by? Is it by patient population age, existing health condition, etc.?

33:35 -- What are you seeing in terms of requirements from notified bodies? Are you seeing consistencies or best practices?

43:06 -- How is the State of the Art defined for SaMD/MDSW, especially those without a specific clinical indication (e.g. Class A IVD SaMD)?

46:36 -- For clinical evaluation of custom made (vascular) devices, does it make sense to compare to SotA data on alternative treatments to confirm safety and performance? Considering alternative treatments have generally be ruled out for these patients if a custom made device is being considered.

55:14 -- How do you suggest to approach areas with several standards/guidances published addressing things that more or less overlap - e.g. cybersecurity?

1:00:48 -- What is your best tip or your best piece of advice?

This is audio from RQM+ Live! #61, recorded 13 October, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

Each year RQM+ supports hundreds of FDA 510(k)'s and EU technical documentation files for either medical devices containing software or stand-alone software devices. In this show our regulatory experts will discuss both FDA and EU deficiencies and additional information requests associated with software (real case studies), as well as best practices and solutions to avoid these pain points in your submissions.

Panelists:

Questions with timestamps:

2:55 -- Setting the scene with definitions... what is software as a medical device and how is it defined between the EU and the United States?

3:54 -- What are the main challenges of software from a demonstration of compliance / regulatory perspective? 9:04 -- What are some best practices for creating software documents to avoid deficiencies?

12:21 -- What are you seeing? Are you seeing significant differences between what the EU and FDA are asking for?

18:29 -- What are the regulation standards and documentation requirements for cybersecurity?

23:51 -- If software developers define user stories as their starting point, are additional dedicated software requirements needed?

26:48 -- We are talking about what is needed to make notified bodies or FDA happy... however, the killer point is getting the software engineers into a practical management of requirements, unit, integration testing, etc.

37:00: -- Does a manufacturer need to audit its cloud provider?

39:00 -- Regarding the responsibilities, when a software device is sold and installed in a hospital or a clinical institute, if the software device is disconnected from the Internet and could not perform the functions as designed, who should be responsible for the impact on the patient? The hospital or the manufacturer? Same question: what if the device was hacked?

43:25 -- You just mentioned the connection between SRS and SDS... is traceability between requirements and design critical in your opinion? It seems desirable as it helps add clarity and understanding for the reviewer but also relative to the quality of the design process. Traceability to verification (requirements to verification) is critical, but wondering about requirement to design.

46:24 -- What have you been seeing with AI and machine learning?

52:50 -- What about wearables and AI / machine learning?

55:42 -- Do you have a final piece of advice for our listeners or top tip?

This is audio from RQM+ Live! #60, recorded 22 September, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

Several RQM+ industry leaders contributed to this year's program at the RAPS Convergence in Phoenix, and we’re ready to share what we learned — and what surprised us — from the event. We also answer your questions in the process!

This RQM+ Live! show discusses the biggest takeaways and surprises from this year's RAPS Convergence. We cover at least a little bit of the subject matter in each of our speaker's sessions, including:

Panelists:

Questions with timestamps: 

3:34 -- Please let the audience know what you spoke about and any key takeaways from the session?

9:24 -- This being the first year back in person after being virtual and hybrid, what did you observe about this conference? What about the attendees?

13:54 -- What was the most unexpecting thing or key learning that you took away from the conference?

24:24 -- Have you also discussed how clinical data and endpoints should be defined when a legacy device has an equivalent device that is now a similar device under MDR, where the legacy device has not yet been placed on the market?

26:27 -- What are we seeing in clinical trials?

28:08 -- What did you hear about surveys?

30:07 -- Am I going to get specifics about my type of device at this conference? Carlos, can you speak to IVD aspect?

33:29 -- How about on the device side... were there a good range of topics and product types represented on the Convergence agenda?

36:38 -- Is it a study if it's a retro chart review that collects personal health information?

40:04 -- What were your takeaways in terms of what's on people's minds and what's bothering manufacturers right now?

42:21 -- What's new with digital health?

43:53 -- How about companion diagnostics?

48:04 -- Did you hear any conflicting advice or things that you did not agree with?

55:08 -- Where is next year's conference?

This is audio from RQM+ Live! #59, recorded 21 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

MDCG 2022-2 was intended to provide guidance on how to demonstrate clinical evidence, however we continue to receive so many questions and requests for support around this topic. The concept that clinical evidence is not clinical performance can still be hard for manufacturers to get their heads around, especially considering the cost and effort it will take to demonstrate clinical evidence.

We discuss:

Panelists:

Timestamps:

3:33 -- What exactly is clinical evidence under IVDR and how much of it is a jump compared to the IVD directive?

7:44 -- We're getting a lot of questions related to clinical evidence and it seems to be what everyone is talking about - why is this such a hot topic?

21:32 -- For CDx, if clinical trial with the US test site and EU collection site the device won't be used anywhere except the US, do we have to register with a competent authority?

22:33 -- If a method comparison should not be considered as a clinical performance study, can you define clinical performance study? What is expected in terms of sample sources and sites for a clinical performance study?

26:32 -- How should manufacturers demonstrate clinical performance under the IVDR?

32:58 -- Our experience with NB other data source is only supporting data but peer reviewed lit and routine diagnostic data can be used. [panelists discuss]

34:07 -- How many patient samples need to be tested for Class C IVD test for IVDR clinical performance?

35:26 -- Any comments related to the clinical performance and evidence monitoring, especially during electromagnetic capability testing under 60601.

36:45 -- Could you please expand a bit on EQI schemes?

39:30 -- How often do you have to update PMPF?

41:37 -- Problem: legacy device (class III, implantable) never implanted to date; start of registry (register) with CRO in 08/2022 but no clinical study running. [panelists discuss]

43:13 -- What would you say the highlights were in the MDCG clinical evidence guidance that was published in the beginning of the year for IVDs?

49:30 -- In order to establish clinical evidence for blood IVD assay, we are struggling to find a laboratory medicine standard on what accuracy is required for a specific analyte (e.g. cholesterol). Suggestions?

52:16 -- How does physically moving device production from one facility to another impact IVDR registration or existing 510(k)s.

53:07 -- Can we quantify benefits for IVD? We currently do a qualitative assessment.

54:45 -- What is required to demonstrate State of the Art for IVDs?

This is audio from RQM+ Live! #58, recorded 14 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

Companion diagnostics (CDx) are critical to patient safety when taking potentially life-saving drugs, e.g. in oncology. CDx can help identify which patients will benefit from a specific drug treatment to improve patient outcomes and identify those patients who have an increased risk for serious side effects from a certain treatment. Hence, CDx are essential in the evolution of precision medicine “providing the right therapy to the right person and the right time” and helps tackle rising healthcare costs, by minimizing drug use to only those who will definitely benefit from a drug.

CDx is an in-vitro diagnostic medical device which are governed by the IVDR in Europe and need to undergo a CE-marking process with a Notified Body to place the CDx on the market. The CE-marking conformity assessment includes a separate consultation procedure between the NB and a medical authority, depending on who is responsible for the authorization of the corresponding medicinal product.

The regulatory framework for drugs and CDx (IVDs) in Europe are governed by two different European legislations with separate registrars. The terminology of these two legislations is not fully aligned which leads to confusion across all stakeholders, the medicinal agencies, the Notified Bodies and the CDx manufacturer. A notified body working group on CDx has taken on this challenge, trying to align multiple notified bodies and the European Medicines Agency (EMA) on the expectations for CDx.

Our expert panel includes TÜV Rheinland’s CDx Teamlead Rolf Thermann, who is also the leader of the notified body CDx working group. Rolf’s role includes building a successful team of experts for auditing and certification of CDx manufacturers, interacting with key opinion leaders in the field of personalized medicine/CDx and establishing communication channels with relevant authorities. In this show, we discuss areas of confusion in industry and notified bodies, and what manufacturers can expect, including:

We’ll kick off this panel discussion with a brief presentation by CDx expert Rolf Thermann. Our panel also includes Heike Moehlig-Zuttermeister and Carlos Galamba – both of whom are RQM+ VPs of Intelligence & Innovation, and former BSI IVD Technical Team Managers and IVDR implementation leaders. Heike and Carlos are now working on the consulting side of industry, supporting manufacturers with challenging IVDR submissions.

Panelists:

This is audio from RQM+ Live! #57, recorded 30 June, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

At RQM+ we're often asked about the FDA appeals process and if it's worth the effort and perceived consequences. The thought of going head-to-head with FDA is intimidating, especially to small medical device companies trying for their first product clearance/approval.

Our panelists recently supported a client with the appeals process and successfully overturned FDA's NSE (Not Substantially Equivalent) determination, so they bring incredibly fresh insight on the process. These panelists include a former FDA CDRH rep who worked on appeals from the FDA side, as well as Mark DuVal of DuVal & Associates, PA: a law practice with a truly excellent success rate in FDA appeals.

Our Live! show discussion will include:

Panelists:

Timestamps:

3:07 -- Dan, this is your story. Could you give us the highlights?

8:37 -- [Mark takes over]

13:23 -- [Mark discusses clinical position]

14:55 -- [More outlining of lengths Linear had to go through to accomplish this]

20:29 -- Besides technical issues, did you have any administrative problems?

24:30 -- Was Linear's experience typical or does this look different than most of your appeals?

26:46 -- Do most startups fold long before this?

28:19 -- What's it like on the FDA side of these appeals?

30:34 -- Is there insight you can provide to those listening? How as a sponsor can we get to those dialogues?

35:47 -- How does FDA feel when they're being challenged in these appeals?

40:20 -- Is everyone even talking? Does it matter that there are 483s in one division and another division is doing an appeal?

41:33 -- What are some scenarios that are good candidates for an appeal?

47:12 -- Are you see an increase in appeals?

53:03 -- We submitted a Pre-sub and it took 10 months for a response (after they changed the date 3 times) and when we got the feedback the questions weren't even answered just pointed to guidance docs and no opportunity to discuss the feedback as an option provided.

54:10 -- What recommendations would you have for FDA to provide the PhD graduates with the appropriate regulatory perspective? How might the industry help FDA?

This is audio from RQM+ Live! #56, recorded 9 June, 2022. To join us live for future shows and ask your own questions, please view and register for upcoming sessions in the Knowledge Center at our website.

RQM+ is bringing together expertise from the world’s largest notified bodies, TÜV SÜD and BSI, to discuss IVDR implementation challenges and lessons learned so far. A lot has happened since October 2020, when notified bodies issued the first IVDR certificates.

In this session we will discuss:

Our three featured panelists are:

Questions:

3:10 -- How did you end up working in the diagnostics sector and what is your role at the notified body?

21:36 -- With only seven notified bodies designated so far, capacity issues seem to be ongoing. Do you see changes coming?

32:01 -- Let's talk about the application process in more detail... we're finding many manufacturers are struggling with this process - can you tell us some of the main issues notified bodies are seeing?

42:18 -- How can we be compliant as much as we can if the notified bodies don't know how to be compliant?

44:44 -- Let's talk about conformity assessment: once the manufacturer completes their application, what are the next steps and how long will it take before the file gets reviewed and they can expect a certificate?

50:25 -- How are you dealing with virtual manufacturers?

59:28 -- For Class D devices, we are not aware that any IVDR certificates have been issues yet for high risk devices. When can we expect the first one to be issued?

1:02:19 -- Do you have any final recommendations for our audience as they prepare for IVDR?

This is the audio from RQM+ Live! #55, recorded 19 May, 2022. Listen and learn why the MDR / IVDR labeling requirements are a great opportunity to start with a blank slate and achieve global market compliance.

Medical device and IVD labeling has always been a challenge for manufacturers because updates are often required when new regulations are introduced. With the piecemeal approach that is commonly taken, the result is a product box covered in labels or inconsistent language and placement across product lines. This can be confusing and overwhelming for end users.

With the implementation of MDR and IVDR requiring significant labeling revisions, manufacturers should consider it an opportunity to start with a blank slate to both achieve global market compliance and eliminate duplicate and inconsistent information.

The reality is that labels will always need to be updated, and manufacturers need processes and systems for:

Led by global regulatory experts with more than 25 years of experience, this show will discuss how to start over with labeling and create a streamlined process for future updates. By making an investment now, manufacturers will see long-term benefits, such as minimizing the impact of future updates and better streamlining for managing large-scale changes.

Panelists:

Questions:

2:35 -- What do we mean by labeling?

3:48 -- What kind of issues are you seeing, especially resulting from MDR implementation and the new labeling considerations?

9:31 -- Does labeling expand into the website content?

12:34 -- As long as your labeling is compliant, why should anyone care and consider starting from scratch?

23:04 -- Can we still supply our product with the same CMD labeling until the conformity assessment is completed or should we change our labeling?

24:18 -- Say I believe that I could save money and heartache in the long run if I overhaul my labeling... where do I start and what are some best practices?

29:06 -- Do you find that people are confused about what's really required?

38:16 -- Thinking globally, if I have to put the names and addresses of the local authorized reps for all of the countries on the label for my software device, is it compliant to put only a URL on a label that links to a website with all my ARs?

40:08 -- How far away are we from utilizing barcoding to cover common symbology translations and also legal manufacturer and economic operator addresses where there will be several to include in the UK, EU, and Switzerland importation.

41:43 -- In the EU, since we are using symbols from ISO 15223 which is harmonized under MDR, no symbol glossary is needed in the IFU. Can we supply this same IFU to the US without the symbol glossary?

45:36 -- How do you overcome labeling requirements for products that are small in size?

47:49 -- What are the types of products or scenarios where you'd say, it's time... it's time to overhaul my labeling?

This is the audio from RQM+ Live! #54, recorded 5 May, 2022. Listen as our panelists provide insight on the changes in the new requirements and what steps companies should take to update their quality system.

FDA requires companies to conform to the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 820). However, many other international regulatory authorities require compliance to the internationally recognized regulatory requirements of ISO 13485.

This misalignment has created extra challenges for companies who market devices in multiple countries, as they have to meet two different sets of requirements. After many years of effort, including participation in the Medical Device Single Audit Program (MDSAP), FDA has released a proposed rule to amend the CGMP requirements of the QS Regulation to align more closely with ISO 13485:2016. While 21 CFR 820 and ISO 13485:2016 share many requirements, there are various differences regarding risk management principles, quality system record requirements (i.e. Device Master Record, Design History File, Device History Record), labeling and packaging controls and others. While this creates the opportunity to have one quality system to address all country requirements, companies need to update their quality system to ensure it complies with the new requirements.

In this show, subject matter experts including former FDA CDRH representatives provide insight on the changes in the new requirements and what steps companies should be taking to update their quality system.

Panelists:

Questions:

2:28 -- Is the FDA actually proposing to adopt ISO 13485 or just proposing to be close to it?

4:52 -- Why are they just not adopting it?

6:23 -- What is an overview of the changes to part 820?

8:18 -- In terms of timelines, where is the FDA on its journey of adopting ISO 13485?

10:00 -- Will the FDA keep in lockstep with SIO 13485 updates?

11:10 -- As new technologies come into play, how receptive are they into adopting SaMD lifecycle, requirements and guidance, etc.?

14:18 -- When the two standards are sort of in one, what are the significant changes that manufacturers will observe?

18:10 -- Commentary on MDSAP...

20:21 -- What kind of impact will the change and adoption have on the FDA?

24:30 -- Does all of this allow you to streamline what you have? Can this be a reset button?

26:47 -- What should manufacturers be doing now as we prepare for this transition?

29:17 -- If you're part 820 compliant and have 13485 as certification, are you already compliant with this new initiative?

32:29 -- What would RQM+ do if we were engaged?

33:37 -- Is this just another step in harmonization?

This is the audio from RQM+ Live! #53, recorded 21 April, 2022. Please note we have not listed the questions asked during the show in this description because there were too many to fit! You can still see a list of them on the video recording page after filling out the form on our website here.  

Our Live! discussion topic "PSURs - Ready, Set, Go!" on 24 February had record-breaking attendance, which means scheduling a sequel is a no-brainer. The discussion between the audience and our expert panelists was extremely engaging and could have gone for hours, so we're back for part 2.

It's obvious that industry is very concerned with the upcoming MDR and IVDR deadlines related to PSURs and unfortunately, there is still a lot of uncertainty and confusion. We're here to help! In part 2 of this discussion, we'll begin with audience questions we didn't get to last time, including:

Panelists:

-

Stay informed:

-

About RQM+

RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. We deliver transformative solutions by providing unrivaled collective expertise fueled by our passion for client success. Our team is collaborative, laser-focused on client needs, and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

This is the audio from RQM+ Live! #52, recorded 7 April, 2022.

During our previous show on this topic we were flooded with questions from viewers (which we love!) and couldn't answer them all, so we're back for a sequel.

Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge.

Rollover questions we'll kick the discussion off with:

The panel of subject matter experts, including former FDA CDRH and BSI leaders:

Questions:

2:28 -- Have you had any unique or unexpected feedback from notified bodies or the FDA? Have you seen any misinterpretations?

9:26 -- Does the FDA influx of new staff factor into the micromanaged questioning and more rigorous approach?

13:20 -- Are we seeing any delays because of laboratories being backed up?

16:50 -- Are there trends from the FDA on adopting biocompatibility testing? Is there an uptake for special 510(k) submissions?

18:02 -- Has anyone had FDA pushback on LCMS ionization mode justification ACPI vs. ESI? (more context added throughout question)

23:29 -- Has anyone had any experience with questions on biocompatibility over the lifetime? If the device is reusable, should the cleaning agents be incorporated in the testing as well?

26:57 -- What testing do you recommend to confirm that a suspected cleaning operation doesn’t leave the part with significant contamination; e.g., cleaning off mold release or stainless-steel solder flux?

30:10 -- How are we advising our clients with legacy devices and their approach?

32:44 -- How do you use exemptions for intact skin devices made of common materials (U.S.)?

36:58 -- Differences between physical and/or chemical information vs. chemical characterization... what are your thoughts?

39:40 -- What do you do if you have a large number of unknowns in chemical characterization?

41:20 -- What about devices that are compatible with chemical characterization?

43:30 -- Do the manufacturers need to provide any evidence for their CrCo device whether the cancer and death cases reported in their PMS are not related to Cobalt content in the device?

This is the audio from RQM+ Live! #51, recorded 24 March, 2022. 

In this session, our panel of clinicians (including a neurosurgeon and anesthesiologist) will discuss ways that they work with regulatory affairs teams to improve outcomes for submissions, including the following:

Panelists:

Questions:

1:50 -- What are the areas of the regulatory process where you think we could be leveraging medical directors more?

5:23 -- Have you found other reasons why else it is important to involve clinicians in your submission process?

10:18 -- As an FDA reviewer (to Dulciana), could you see submissions that involve clinicians vs. not, or where intended use is off-base?

11:03 -- Do you think there is going to be a problem with titling these indications, and therefore... clinicians being used to their old ways... using devices almost off label?

14:47 -- How can you include your external medical experts in your QMS processes and training to be able to participate in an organization's procedures for risk management and clinical evaluation?

17:27 -- Scoping State of the Art has been a huge challenge. How could clinicians help with that?

23:07 -- Can you use the designing surgeons to be part of the process?

27:37 -- One process for early understanding of the level of clinical data needed for MDR certification is through ‘proposed clinical path review’ by the NB. But the same NB glut and delays observed for cert. are similar for this vehicle (NB clinicians appear to be too busy with cert. to even address clinical path review). Are there other approaches for companies to understand what level of clinical evidence is needed prior to submission of a full application?

39:57 -- Could you enlighten us on where the border between consulting and providing information stands?

41:57 -- Where is that line when it comes to FDA?

44:25 -- What's your opinion on software as a medical device, trends on classification, and how to take help from clinicians for scoping?

47:36 -- What about CERs and PERs, specifically?

52:30 -- Are there any key takeaways to wrap up? (includes commentary on PMCF and an overall summary)

This is the audio from RQM+ Live! #50, recorded 10 March, 2022.

A "notified body application" for IVDR CE certification can feel like 510(k) submission to IVD manufacturers who are new to the notified body relationship. Notified bodies are quoting a range of < 1month to 6+ months review time based upon application quality. Per the notified bodies, the majority of applications have problems, so a 6+ month review time is currently the norm.

Errors and deficiencies are commonly found in the intended purpose, classification, code assignments, acceptability of product groupings, and verification and description of activities of suppliers, subcontractors, and manufacturing sites.

In this Live! show featuring former notified body representatives fresh out of their IVDR leadership roles, we'll discuss best practices for delivering accurate and compliant applications that will be reviewed efficiently, and accepted by the notified bodies.

Panelists:

Questions:

2:35 -- Let's define the term notified body application and ask... why is it an important step of the process?

8:51 -- Is the application the same for all notified bodies?

11:39 -- When should manufacturers start the application process?

19:18 -- What are the key components that are part of the notified body application?

34:43 -- If we need a brand new device certification from a notified body we've never worked with before, the process starts first by contacting them on the website and then the application process starts... what does that look like? What kind of documentation is required when you think about the application process versus just contacting and shopping for a notified body?

39:47 -- If we're going to launch a novel or innovative IVD in Europe in 2025, when would we need to engage a notified body?

44:52 -- Let's talk about pricing... can we negotiate our pricing? What does this proposal really mean? What exactly are man-hours?

51:06 -- Any final lessons learned or best practices to share with everyone listening?

This is the audio from RQM+ Live! #49, recorded 24 February, 2022. The session description below has been abbreviated significantly in order to list the questions covered. You can read the full description here.

Whether you've already created PSURs and are looking for ways to optimize and improve, or haven't started yet, you'll want to hear our panel of experts discuss best practices and lessons learned based upon case studies of successes, failures, and notified body feedback so far.

Questions:

2:24 -- What is your experience so far with supporting the industry with PSURs?

3:35 -- Have you had any notified body feedback yet on PSURs?

10:54 -- Is there any news on when the guidance is coming?

12:20 -- What needs to be covered in respect to same/similar to medical devices in PSURs?

14:47 -- Any best practice for implementing expected undesirable side effects to our end process?

16:12 -- What is the team's view on whether a CER should always be updated following an update of the PSUR and what are the different purposes of the PSURs vs. the CER? [link to RQM+ webinar referenced]

18:25 -- When does the first PSUR for medical devices need to be prepared according to EU MDR?

20:35 -- Where are you really seeing manufacturers first struggle? Where's that first hurdle?

22:47 -- From a notified body perspective, what are people missing in their PSUR programs?

29:14 -- Could you please discuss how the PSUR is related to the PMS Report and PMCF Report? Or all three documents required or can we only provide a PSUR?

30:49 -- What time period should be considered in a PSUR?

31:42 -- The draft PSUR guidance we've seen from MDCG notes the first PSUR being due December 2022 for Class III and IIb. Should this be taken with a grain of salt until guidance is finalized?

33:49 - How should we handle adverse events if our device is very new?

34:28 -- Interesting comment from the audience: their PSUR was inspected onsite in an annual QMS audit in August of 2021 by BSI.

34:48 -- Back to same/similar, when the company itself has same/similar products which are not medical devices, where you would have a lot of information like sales volume complaints as well, should that also be included in the PSUR or is that overload? (reference to mouthwash)

37:14 -- A lot of the information required by PSURs seems redundant to the information contained in the CER for the medical devices. How does this info need to be reported and analyzed differently in the PSUR, if at all.

38:05 -- What happens if there is a lot of clinical data on a similar device that is not marketed anymore in Europe, but it was marketed before? Can we use that data for comparison with our device under evaluation?

39:37 -- How would a manufacturer of a reusable surgical instrument that is categorized as Class IIa calculate a complaint rate for a five-year period when the devices cannot be used beyond the five-year PSUR review period?

40:41 -- In the absence of IMDRF codes for summarizing non-serious incidents, is it acceptable to use internal coding or should internal coding be translated to the applicable IMDRF code?

41:23 -- How soon do you expect notified bodies to require IMDRF coding only for PMS data presentation in PSURs?

41:55 -- How do we select similar devices - can we select a few or should we include all in the PSUR?

42:31 -- Is there any requirement to conduct a technical literature review in the context of the PSUR?

43:06 -- Should benefit-risk analysis be part of the PSUR or CER?

45:55 -- Population using the device - should it be understood as a patient

This is the audio from RQM+ Live! #47, recorded 27 January, 2022. The session description below has been abbreviated in order to list the questions.

The equivalence requirements of MDR Article 61 Sections 4 and 5 have been interpreted conservatively thus far by notified bodies and industry. It's simple – for Class III and implantable devices, the manufacturer cannot leverage data from an equivalent device unless the equivalent device either belongs to that manufacturer or that manufacturer has a contract with the equivalent device's manufacturer allowing access to their data. If those requirements cannot be met, the MDR states that the manufacturer must undertake clinical investigations.

Panelists:

Questions:

2:30 -- Amie, you wrote an opinion paper on the equivalence requirements of MDR Article 61. Can you share why you wrote the paper and summarize your points?

5:30 -- Flowchart shown (video recording only)

9:25 -- Was there a specific device you were working on that spurred you to finally write this down?

12:15 -- Are there any other specific devices you have come across where this would be really helpful?

14:24 -- What devices would this not apply to?

23:13 -- How likely do you think it is that notified bodies would accept this? Have you heard any feedback yet?

27:16 -- If a new device is a further development of a current marketed device, is it possible the clinical data for that marketed device to be still applicable for the next generation device without claiming equivalence provided that there are no expected differences in clinical performance?

28:37 -- If two devices belong to the same generic group, does this mean they need to be equivalent?

29:08 -- For MDR, it shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence. Examples of what conditions would satisfy this requirement?

31:39 -- Is it the case that if the company doesn't have access to the technical file of the equivalent device, that the equivalence argument cannot be substantiated even for Class I-11b devices.

32:16 -- A new WET device as defined by the articles such as a plate or pin which is not CE marked under either MDD or MDR that has no equivalent device, the language in 61-6b would initially lead the reader to believe a clinical investigation is not needed. But the caveat is, without an equivalent device or common spec, you can't support the notion that there is sufficient clinical data, thus a clinical investigation is indeed required. Thoughts?

36:37 -- Is it safe to conclude that Article 61-5 is not applicable to Class IIb or lower, in other words, if Class IIb non-implantable can claim equivalence to another manufacturer's device without access to the tech file, that's OK.

37:58 -- If there any change in the design of a device, does it need to go through the same route - I will use the spinal cage as an example - if there is a new design change in shape in the spinal cage, is it considered a new device category or can it go under the spinal cage category?

40:55 -- What do you recommend companies do right now with this new information?

43:23 -- What else will the naysayers say and why are they wrong?

This is the audio from RQM+ Live! #46, recorded 13 January, 2022.

As we enter 2022, we'd like to reflect on what's happened over the past year in the world of FDA and medical devices. We'll be sharing our insights to how the Agency did in 2021 and a recap of the most important, cross-cutting regulatory changes. Additionally, we'll provide a forecast of what we can expect in 2022.

This discussion will cover the following and more:

The panel of former FDA CDRH and industry subject matter experts:

-

Questions:

3:40 -- What was 2021 like on the inside at FDA?

13:21 -- Could you summarize the updates and changes at FDA in 2021?

14:52 -- Allison, you've worked on many STeP applications - what's been your experience?

20:08 -- Let's talk about the eSTAR program... good, bad, any experience with it so far?

27:21 -- What is new in digital health at FDA?

31:58 -- Are you able to get Q-Sub meetings now?

33:17 -- What's taking up FDA's time? It can't be EUA's, right?

35:37 -- Is there any data on the clearance time using eSTAR? (the answer is no)

36:00 -- How about the status of EUAs... what's going on with them?

40:35 -- Any other impactful changes at FDA that people should be aware of from 2021?

46:47 -- What about biocompatibility?

48:10 -- How about MDUFA?

49:06 -- Any other key things anyone wants to point out before we wrap up?

-

Next RQM+ Live! show:

-

Stay informed:

-

About RQM+

RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

This is the audio from RQM+ Live! #45, originally recorded 16 December, 2021.

Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge. In this show, we will discuss the changes to standards in recent years, what’s on the horizon for 2022, and answers to common questions we receive like the following:

Here's the esteemed panel of subject matter experts, including former FDA CDRH and BSI leaders:

-

Next RQM+ Live! show:

Stay informed:

-

About RQM+

RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

This is the audio from RQM+ Live! #43, originally recorded 11 November, 2021.

MDCG 2021-24: Guidance on Classification of Medical Devices was released in October 2021, clarifying spinal implantable medical device classifications.

Related MDR language published in 2017 left room for interpretation. In the absence of official guidance over the past 4+ years of transitioning to the MDR, manufacturers made the case for IIb classification, which was reinforced in 2018 when Team NB published a position paper stating that many spinal implants are Class IIb since they are wedges. MDCG 2021-24, in conflict with that paper, is setting off alarms across the industry as spinal implant manufacturers come to the realization that they have a lot more Class III devices than they planned for.

What is the impact of class III designation to manufacturers? Will additional data be needed?  Will existing clinical evidence be sufficient?  Will the increased frequency of CER updates and PMCF reports require more resources?

Join industry's leading experts, including recent notified body leaders and medical experts, for a discussion of these questions along with solutions and next steps you'll want to consider.

The panel will include:

-

Upcoming events:

Stay informed:

-

About RQM+

RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

This is the audio from RQM+ Live! #42, originally recorded 28 October, 2021.

When we say RQM+ IVD Director Carlos Galamba is no stranger to the IVDR, we really mean he is no stranger to the IVDR! Carlos is not only fresh out of BSI, but was one of three technical managers developing their IVDR program. Since BSI covers close to 50% of the world’s top IVD companies, we think the perspective and experience Carlos brings to the table is absolutely invaluable.

This special edition of RQM+ Live! will be all about sharing his perspective and experience with you.

Having been in the unique position of 2 IVDR notified body designations at BSI, Carlos is completely in the know about how notified bodies are interpreting and implementing the regulation, and what IVD companies can sincerely expect from BSI and other notified bodies. We're unabashedly biased, but if you're in the IVD space, we think there are very few experts out there that would make for a better Q&A session around the IVDR than with Carlos.

Carlos will bring his top-asked questions that he's compiled from when he was with the notified body, and we encourage you to bring your own questions for him! He'll answer them live. When it's all said and done, we're conducting this session so we can help answer your questions, so don't be shy! We think you'll find that Carlos isn't.

Click here to read more about Carlos' notified body involvement and extensive background.

-

About RQM+

RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

This is the audio from RQM+ Live! #41, originally recorded 14 October, 2021.

Your post-market surveillance (PMS) system complying to the EU MDR was put into place in May 2021. How is it going? Now months later, there are an abundance of issues and questions! 

This panel discussion provides a unique opportunity to learn from the experiences of seasoned experts as they share PMCF successes and failures they’ve seen across the industry so far. While there have been and will continue to be plenty of implementation challenges, our esteemed panel has worked through comprehensive solutions and is anxious to share.

Discussion will include:

The panel will include:

-

About RQM+

RQM+ is the leading international provider of regulatory, quality and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

This is the audio-only version of RQM+ Live! #40, originally recorded 30 September, 2021.

This has been a very common question from device manufacturers since FDA issued guidance on “least burdensome” almost 20 years ago. FDA defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.

Some manufacturers have strong opinions about pushing back on FDA with the argument of utilizing the least burdensome approach, while others are very hesitant to burn bridges. What’s the best approach to get the results you desire while not becoming FDA’s arch nemesis? Join our regulatory experts including former FDA CDRH representatives for a detailed discussion on the process and best practices for disagreeing with FDA.

The panelists:

Questions answered:

-

About RQM+

RQM+ is the leading international provider of regulatory, quality and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

This is the audio-only version of RQM+ Live! #39, originally recorded 26 August, 2021.

The climb to MDR certification is well underway for device manufacturers. It's been quite an undertaking, but with careful planning, budgeting and execution, it has and will lead to continued successful commercialization of medical devices and IVD’s in the EU. However, achieving certification is just the beginning. Compared to the MDD and IVDD, it will be quite challenging keeping up with all the new requirements for post-market reporting and documentation updates that these trigger. And although many IVD manufacturers are just getting started on the journey to IVDR certification, given the sheer volume of new requirements, the earlier you to start preparing for the post-market phase the better.

With heftier regulatory files to maintain, highly detailed clinical evaluations and PMCF/PMPF plans, many new PMS reporting requirements, and expectations for much more coordinated review of and updates to regulatory, clinical, and risk documentation at a higher frequency than ever before, it's critical to start considering how all of this will be accomplished in the years ahead. Something like a "simple" design change may never have the word simple in front of it again when considering the impact of any product modification across functions and documentation.

In this show we'll talk about what life will look like for regulatory, clinical, quality and PMS functions as we enter MDR/IVDR sustaining mode, and continue to support getting new products to market. Please bring your questions for our experts… we're here to help!

The panel will include:

-

About RQM+

RQM+ is the leading international provider of regulatory, quality and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

This is the audio-only version of RQM+ Live! #38, originally recorded 22 July, 2021.

Market consolidation and acquisitions along with the relocation of design centers and manufacturing facilities to OUS locations are resulting in what appears to be a continuous cycle of site transfers for medical device companies. RQM+ is a strategic partner to these companies, providing all things regulatory and quality associated with the transfers. Our subject matter experts have case studies, lessons learned and best practices across activities in regulatory registrations, quality systems, process validations, project management, and remediation. In this show we'll discuss solutions to some of the biggest gaps and challenges we encounter, including

Join our discussion and bring your questions for our subject matter experts! They'll be ready and excited to answer.

The panel will include:

-

About RQM+

RQM+ is the world's leading (and largest) medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of RQM+ Live! #37, originally recorded June 17, 2021.

The U.S. FDA provides multiple pathways to expedite regulatory clearance/approval for much needed innovative devices. As a regulatory consultancy, we've had the opportunity to support manufacturers achieve successful entry to the market using these various pathways. We're very excited about FDA's recently released Safer Technologies Program (STeP) Guidance Document which fills in the gaps for devices that target important conditions that are not covered by the Breakthrough Devices Program and provides another mechanism to get safer treatments more quickly to the patients who need them.

We often get the questions, "Where do I start?" and "How do I know if my device qualifies?" In this Live! show, our panel of regulatory experts (including former FDA CDRH representatives) will discuss the following and more:

If you'd like to learn more about the options and challenges associated with getting innovative devices to the US market, please join us and bring your tough questions for our panel to answer live!

The panel will include:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio recording from our panel discussion at the MassMEDIC Mid-Year FDA Update event held on April 20, 2021. You can watch the panel discussion on our website here. RQM+ is an Associate Member of MassMEDIC and is sponsoring their FDA series this year (look for another event in December). We're always delighted to collaborate with the team at MassMEDIC.

FDA Submissions in 2021: How's it going?

With a focus on FDA regulatory submissions, this panel discussion will provide context for what occurred in 2020 and early 2021, and provide forward-looking guidance and expectations for the remainder of the year. Will the rest of 2021 be smooth sailing or is there turbulence ahead? Our panel of esteemed regulatory experts, including former FDA CDRH representatives and regulatory leaders from multi-national medical device manufacturers, will discuss their thoughts on FDA focus areas, new guidance documents, and requirements on the way, along with the continued impact of COVID-19 on FDA resources and submission timelines. They’ll also react to FDA Director of the Center for Devices and Radiological Health Jeff Shuren’s presentation being held immediately prior.

The panel includes:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of RQM+ Live! #36, originally recorded June 3, 2021.

We're back for part two! With so many questions we couldn't address during our April 22, 2021 show on this topic (available on demand), we needed to come back a second time. This is clearly a topic many of you are interested in and we want to help, so here's a second chance to learn from RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day.

"Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more:

Our panel includes Amie Smirthwaite, former Head of BSI Global Clinical, and Jai Kutty, just months out of BSI, along with RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day!

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of RQM+ Live! #35, originally recorded May 20, 2021.

PSUR - Periodic Safety Update Report - is a new report required by the EU MDR and IVDR. Device manufacturers must have their PSURs ready for review in May 2022 for Class IIb and III devices, and May 2023 for Class IIa devices.

It may feel like there is plenty of time to prepare and no need to start yet, but it's important to recognize the amount of work involved in implementing this new process for an entire portfolio. Identifying database limitations, finalizing a process and template, and finding efficiencies will be keys to creating a smooth process. Similarly, Health Canada's new requirements for post-market summary reports and issue-related analyses for Class II, III, and IV medical devices come into force December 2021. Starting implementation of both the PSUR and HC Summary Report requirements now will enable time to establish an effective and efficient process that doesn't drain your resources.

We're supporting clients with implementation and have received many questions. Here are some of the questions that we plan to discuss in this show:

Please bring your questions for our SME's and former notified body leaders to answer LIVE!

Panelists:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of RQM+ Live! #34, originally recorded May 6, 2021.

We all have the same goals when submitting technical documentation to the notified body for review:

There are many strategies to improve your odds, and this panel of experts knows them well. We'll discuss the easy solutions, such as simply using terminology and organizing your file in a way that the notified body reviewers expect. This may sound obvious, but we've all worked at manufactures who wanted their regulatory files to be different than recommended.

We'll also discuss more complicated but necessary strategies, like telling a consistent story of clinical evidence across promotional claims, risk management, clinical evaluation, and post-market surveillance.

Many of us like to use the metaphor that while you may all be wonderful singers individually, if you are each singing from different sheet music... well, it will sound awful to the audience.

This panel of subject matter experts includes our esteemed former notified body leaders as well as our seasoned regulatory professionals who have created many MDD and MDR technical documentation files. No matter how long you've been in the industry, we believe that you'll leave this discussion with some new tips and tricks to take back to your team.

Panelists:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of RQM+ Live! #33, originally recorded April 22, 2021.

"Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more:

Our panel include Amie Smirthwaite, former Head of BSI Global Clinical, and Jai Kutty, just weeks out of BSI, along with RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day!

Panelists:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of RQM+ Live! #32, originally recorded April 8, 2021.

The MDR Date of Application is just around the corner, and there is no indication of another delay coming. If some or all of your products won't be ready in time, you may be starting to panic. In this show we'll start by debunking the bad ideas that we've heard. Here are some examples:

The above strategies can put your company's CE marking and reputation with the notified body in serious jeopardy. However, there are effective strategies for staying on the market as long as possible while also remaining compliant. Please join our former notified body leaders and regulatory subject matter experts for an informative discussion and bring your questions and ideas!

Panelists:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of RQM+ Live! #31, originally recorded March 25, 2021.

In connection with biological equivalence, the MDR states, “the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.”

The intent behind using an equivalence strategy in the EU is to leverage the clinical data from the equivalent device via an assessment of risks arising out of any potential similarities or differences that may have an impact of the established safety/performance profile of the equivalent device.

Simple right?  Well actually, no.  This has been a big source of confusion for manufacturers in understanding what equivalence really is and having a consistent approach to presenting it in technical documentation.

Join us for an engaging discussion on practical solutions to establishing successful biological equivalence rationales. We'll cover the following and more:

This esteemed panel is comprised of former notified body leaders and regulatory experts in their fourth year of developing and implementing biological equivalence strategies under the MDR.

Panelists:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of RQM+ Live! #30, originally recorded March 11, 2021.

The first and arguably most critical step in the IVDR implementation process is determining if you have a compliant intended purpose statement. This has proven to be challenging, even for legacy devices, and has already resulted in notified body findings for manufacturers who are getting a head start over others in the industry.

It's important the intended purpose statement be compliant while also serving the business strategy. Considerations are:

In this show our IVDR experts will discuss strategies for developing intended purpose statements, evidence and a compelling story to tie it all together, so that you can continue to market your IVD under the IVDR.

Panelists:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of DEVICE LOVE Live! #29, originally recorded February 25, 2021.

There has been plenty of discussion regarding what "good enough" means with respect to compliance to the MDR and IVDR. There are many new requirements, and the EU is enforcing much stricter interpretations of requirements that existed under the Directives. A recurring theme is that there will be no “grandfathering” for legacy devices, which means that in some cases significant technical documentation remediation may be required (with similarly significant associated costs). There is also a more explicit emphasis on PMS, PMCF, and continual updates of related documentation. At the same time, the MDR requires much greater transparency of information, as evidenced by requirements such as SSCP, and this will require public disclosure of evidence that manufacturers may previously have considered confidential.

As a result, manufactures may choose to "test the waters" first by submitting technical documentation that pushes the boundaries of what may be perceived to be acceptable. However, does this really save manufacturers money in the long run?

You may be surprised to learn from our former notified body leaders and regulatory experts how much this strategy really costs you. Please join us for this eye-opening discussion!

-

About RQM+ RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of DEVICE LOVE Live! #28, originally recorded February 11, 2021.

The MDR and IVDR have significantly increased requirements for clinical, regulatory, and post-market surveillance documentation. To make it even more challenging, there are overlapping requirements resulting in the need for consistent information across a variety of plans and reports. The integration of clinical, regulatory, risk management and post market surveillance is a difficult and confusing task, however, it's essential to ensure consistent information across all plans and reports: CEP/PEP, CER/PER, risk management file, labeling, PSUR, PMCF/PMPF, and SSCP/SSP.

Our experts will discuss how the data inputs and outputs for these documents are interrelated and provide guidance and best practices on how to share information throughout the organization to streamline processes and ensure consistency.

-

About RQM+ RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of DEVICE LOVE Live! #27, originally recorded January 28, 2021.

We’re almost one month into 2021... and we're sure everyone's hoping for a much better year than the last! With a focus on FDA regulatory submissions, we would like to provide context for what occurred in 2020 and provide forward-looking guidance for expectations in 2021.

Will 2021 be smooth sailing or is turbulence ahead? Our panel of esteemed regulatory experts, including former FDA CDRH representatives, will discuss their thoughts on FDA focus areas, new guidance documents, and requirements on the way, along with the continued impact of COVID-19 on FDA resources and submission timelines.

Panelists:

-

About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

This is the audio-only version of DEVICE LOVE Live! #26, originally recorded January 14, 2021.

In this unique episode of DEVICE L❤️VE Live!, the focus turns to Dr. Amie Smirthwaite, Head of Clinical Regulatory Affairs at RQM+, as she answers questions from our recent EU MDR and IVDR email survey. Amie will be covering a multitude of areas, including legacy products, CERs, PMCF, PSURs, and notified body/commission commentary.

Want to learn more about Amie? Her lengthy credentials are listed below! Please join us this Thursday at 11am ET by registering below, and hear her answers... and have a chance to ask a question of your own.

Credentials:

This is the audio-only version of DEVICE LOVE Live! #25, originally recorded 17 December 2020.

ISO 14971:2019 is not yet harmonized to the EU MDR/IVDR, however, BSI has declared that it is the state of the art and is issuing findings against it in MDR audits. Regardless, it is anticipated the 2019 revision will be harmonized to the regulations and therefore, we recommend manufacturers begin the transition.

In this DEVICE L❤️VE Live! show, our expert panelists will discuss the following and more:

Please bring your questions to be answered real time by our experts, including former notified body representatives.

This is the audio-only version of DEVICE LOVE Live! #24, originally recorded 3 December 2020.

The IVDR has detailed requirements for performance evaluation. The new performance evaluation report comprises three separate requirements: scientific validity, analytical validity and clinical evaluation.

The majority of in-vitro diagnostic devices were self-certified in the EU prior to the IVDR. Their legacy status means that the associated technical documentation typically has significant gaps in terms of IVDR requirements, including those upon which scientific validity or analytical performance were based. This means that performance evaluation will be is a formidable task for many manufacturers. To obtain certification under the IVDR, IVD manufacturers must demonstrate performance based on the intended purpose/use, intended user, and other conditions of use such as intended patient population, environment and conditions of sample preparation. Many companies are struggling with the first step of clearly defining the intended purpose, let alone meeting the full gamut of requirements for demonstration of scientific validity, analytical performance and clinical performance.

In this DEVICE L❤️VE Live! session, our panel of experts will discuss what performance evaluation, scientific validity, analytical performance and clinical performance are for IVDs, the steps to generating data that will be accepted by the notified bodies, and our lessons learned so far.

This is the audio-only version of DEVICE LOVE Live! #23, originally recorded 19 November 2020.

As defined by the FDA, Real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, like electronic health records and product and disease registries. With the additional requirements of the EU MDR, RWD can also be gathered from PMCF studies and surveys, and EUDAMED. Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).

More simply put, RWD are the data sources obtained outside of a traditional clinical trial, which are then analyzed to generate RWE or used to define a study to create RWE.  RWE can provide a faster and more efficient method to meet the evidentiary requirements for FDA and EU regulatory submissions, but it is not without its challenges.

Determining what RWD and RWE are and how to apply them for your device can be daunting.  In this show, we will simplify these terms and discuss best practices.  We'll also answer the questions we often receive including the following:

Bring your toughest RWD/RWE questions for our experts to answer LIVE!

This is the audio-only version of DEVICE LOVE Live! #22, originally recorded 5 November 2020.

The Summary of Safety and Clinical Performance or "SSCP" is required by EU MDR for Class III and implantable devices. The SSCP must be reviewed every year, for the lifetime of the device, and is a public facing document. The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device.

The MDCG 2019-9 guidance calls for significant detail that device manufacturers would prefer to keep confidential. As a result, creating an SSCP that meets the regulatory requirements and is acceptable to the Marketing and Legal teams is incredibly challenging. Further complications are having an SSCP that's suitable for patient review, providing multiple translations, and updating this long and comprehensive document annually. 

R&Q has submitted multiple SSCPs and received notified body feedback. Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #21, originally recorded 22 October 2020.

Will collecting the data be successful?

One of the biggest challenges to EU MDR compliance is meeting the requirements of Post-Market Clinical Follow-up. Many device companies are hoping the combination of literature reviews and PMCF surveys will be “enough” because those approaches are much less resource intensive than registry studies and clinical investigations.

In this show our experts will discuss:

If you’re anxious to kick off your survey program but have some concerns, please join us and bring your questions!

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #20, originally recorded 8 October, 2020.

Although the date of Brexit has passed us, the UK continues to modify its stance for manufacturers’ requirements. In this session, we will dive into the new proposals and how they affect you and your medical devices. We will explore the implications of the CA mark (and its comparability to the CE mark), the UK’s position and stated reversal on EU MDR/EU IVDR, and the expected timelines and grace periods for compliance.

This session will contain critical information for any decision-makers doing business in the UK or Europe in the continually turbulent post-Brexit world.

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #19, originally recorded 24 September, 2020.

There's a lot of uncertainty in the industry around meeting the requirements of Post-Market Clinical Follow Up (PMCF) under the EU MDR and Post-Market Performance Follow Up (PMPF) under the IVDR.

It's not easy!

In this show we'll answer popular questions from our clients and as well as live audience questions. So please, bring your challenges to the table: we'll be ready!

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #17, originally recorded September 10, 2020.

The Periodic Safety Update Report or "PSUR" is required by EU MDR for each Class IIa, IIb, and III device, and IVDR for Class C and D IVD's.  It must be updated it at least every two years, for the lifetime of the device.  The PSUR provides a comprehensive risk-benefit analysis with periodic updates, pulling data from multiple sources that may not be accustomed to interacting with each other in an efficient way (Risk Management, CER's, PMCF and PMS/Complaints).   

The requirements in the regulation are new and seem to overlap with existing reports.  We have yet to see any specific guidance or the PSUR template rumored to be in development and if SSCP and PMCF are any indication, it will be extensive.  Where does that leave the industry on how far to go with data and analysis in the initial PSUR, what will be good enough to satisfy the notified bodies? 

Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #16, originally recorded August 27, 2020.

Performance Evaluation Plans (PEPs) and Reports (PERs) are now required under the IVDR. Most companies have never performed PERs, which are perhaps the most complicated step to achieving IVDR compliance. Join R&Q's knowledgeable IVDR experts in a panel discussion of strategies and best practices for developing PEP's and PERs. We'll kick off the discussion with questions we've received on the following topics:

We encourage you to bring your own questions for our experts to answer in real time. Don't miss this opportunity!

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #15, originally recorded August 13, 2020.

The rules of requests for feedback and pre-submission meetings with FDA are covered under FDA Guidance Document, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program," issued May 7, 2019.

The FDA Q-Submission (formerly known as pre-sub) Process can be intimidating, beginning with the decision as to whether to request a Q-sub at all. It's a great opportunity to align with FDA or pressure-test on critical items like predicate assignment or test plans before getting too far along in development and spend, however many fear that FDA is more critical of data in the Q-sub than they would be seeing it for the first time in a 510(k) submission. This uncertainty combined with the time commitment to have one often makes it difficult for an RA lead to get the product development team on board with a Q-sub strategy.

In this show, talk with our FDA submission experts including recent CDRH staff about when to use the pre-sub process, real and perceived risks associated with the process, tips and tricks to achieving a successful meeting, and case studies of our experiences.

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #14, originally recorded July 30, 2020.

Based on the amount of questions we're receiving around the definition of a Well-Established Technology (WET), evidence suggests there's a lot of confusion and in turn, potential impact to the industry. The MDR didn't provide a definition, however, the MDCG-6 Guidance on sufficient clinical evidence for legacy devices now provides a definition and further details around sufficient clinical evidence for WET and non-WET devices. Even with this guidance, we're still seeing debate between device companies and their notified bodies on what is classified as WET.

In this show, we'll provide our current thinking on this debate and some tips for interacting with your notified body.

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #13, originally recorded July 16, 2020.

It can be difficult to keep software clear of being classified as a medical device when used in healthcare. For example, wellness apps are frequently on the fence, and with every added feature you need to reassess the intended use to ensure you haven't crossed the line into medical device territory.

When a software application is used in conjunction with a medical device, it's even more challenging to keep the app clear of being a medical device itself. Regulatory professionals feel the pressure of software developers and marketers who want the speed to market that's needed to win in this competitive environment.

Most of us in regulatory affairs have been asked by our product development teams questions like,

In this show we'll discuss:

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #12, originally recorded July 2nd, 2020.

Whether you're on your first 510(k) submission at a startup or your 50th at a large company, you likely have some anxiety over the unpredictability of the process. Let our submission experts will help ease your mind! The panel includes recent CDRH staff who will discuss their tips and tricks for a smooth 510(k) submission process.

We'll cover best practices in all aspects of 510(k) submissions:

Here's the panel:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #11, originally recorded June 25th, 2020.

Demonstrating "sufficient clinical evidence" is now a clear and enforced requirement for applications under the EU MDR. Additionally, MDR has more explicit requirements to claim equivalency, making it challenging for manufacturers to leverage clinical data generated by other manufactures for similar devices. If you don't have adequate clinical data, what are your options to achieve MDR compliance, especially if you are no longer able to claim equivalency?

In this DEVICE L❤️VE Live! session, our panel will discuss the following and more:

This panel is loaded with former notified body representatives and seasoned R&Q subject matter experts:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #10, originally recorded June 18th, 2020.

The clock is ticking down to the IVDR date of application! May 26, 2022 sounds far away, but it's really not considering the size of the step to IVDR compliance for most IVD companies. The transition from MDD to MDR for medical device manufacturers feels relatively small in comparison to the 85% of IVD companies moving from self-certified to notified body audits, complex regulatory systems, and the expectations of much tighter controls over the web of virtual manufacturing and distribution relationships IVD companies are accustomed to.

This panel will discuss the following and more:

The panel is stacked with former notified body representatives and experienced R&Q subject matter experts:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #9, originally recorded June 11th, 2020.

The FDA 3rd Party Review program has been in use for many years, having been written into law in 1997. On March 12, 2020, FDA released the guidance document, "510(k) Third Party Review Program," based on the draft issued in 2018.

Under the this program, referred to as "3P510k" by FDA, 3P510k Review Organizations review a 510(k) submission and then forward their review, the 510(k) submission, and a recommendation (e.g., substantially equivalent (SE) or not substantially equivalent (NSE)) to FDA. FDA reviews the 3P510k Review Organization’s memo and recommendation and makes a final decision on the submission.

In this Live! session we'll discuss:

If you're contemplating using the program and are trying to assess the risks… great timing!

The panel will include:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #8, originally recorded June 4th, 2020.

With the EU being on the hot seat lately, and all eyes and discussions on the MDR, you might be left wondering...

— What's the latest in FDA trends?

— Is FDA going harder or lighter on inspections?

— Are 510(k) submissions being scrutinized more than ever – in line with the pendulum swing of the European Commission – or is it status quo for the FDA?

R&Q experts will share what we're seeing across a multitude of device companies with varying clinical specialties and geographies. Attendees should expect to get a glimpse of what to expect! We're looking forward to this one and hope you'll join us.

The panel will include:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #7, originally recorded May 28th, 2020.

Under EU MDR, notified bodies are required to look at every technical documentation file at least once in a five-year period. This is alarming for companies with devices marketed 10+ years ago, for which the tech files haven't been reviewed critically since the early years on the market. The risk files for these devices may be thin, and far from compliant to the EU MDR. As an added complication, in the intervening years the Risk Management Standard ISO-14971:2019 has also gone thru a revision. This is the current “State-of-Art” standard referenced for the Risk Management section of the MDR. These changes must also be considered when revising legacy Risk Management Files.

What are some efficient approaches to getting these files audit-ready?

What are the expectations of the notified bodies?

We cover these questions and much more in this Live! session.

Panelists:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #6, originally recorded May 21st, 2020.

Join us for an open discussion with former FDA and Notified body representatives.

— What's it like moving from government to industry? — What do they miss about their previous roles? — Why do they prefer being in industry…or do they? — What do they wish both sides knew about the other? — What are key takeaways to successfully navigate the system?

Panelists:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #5, originally recorded May 14th, 2020.

Join us for an open discussion with former FDA and Notified body representatives.

— What's it like moving from government to industry?
— What do they miss about their previous roles?
— Why do they prefer being in industry…or do they?
— What do they wish both sides knew about the other?
— What are key takeaways to successfully navigate the system?

Panelists:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #4, originally recorded May 8th, 2020.

Remediation programs at medical device companies are very hard on everyone involved.  DHF and manufacturing remediations resulting from government actions (FDA warning letters, EU's non-compliance reports) are the extreme.  The proactive efforts needed for many companies to achieve MDD compliance let alone the jump to MDR are no piece of cake either.   Remediation often exhausts the team, brings down morale, and leads to much debate over what is "good enough".  Let's talk about best practices to enable remediation efforts to be as pain free as possible.

Panelists:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #3, originally recorded May 1st, 2020.

Notified Body auditors have increased scrutiny as promised in both initial Medical Device Regulation (MDR) certification audits and routine Medical Device Directive (MDD) audits. Novel major findings are being issued on long standing processes and legacy products. In this panel discussion, R&Q experts will talk about what we are seeing across the medical device industry. Our experts will provide recommendations on where to focus your resources to increase the odds of passing a notified body audit without major findings.

Panelists:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #2, originally recorded April 24th, 2020.

In response to the COVID-19 global pandemic, health authorities are taking the necessary steps to allow for greater access to and use of critical medical devices and PPE that are in short supply. However,some manufactures lack the necessary regulatory approvals needed to make their medical devices/PPE available. In situations such as these, both the United States (FDA) and European Union (European Commission) have legislation in place to help bring these critical products to patients and healthcare workers for emergency applications.

In the United States, the US FDA has invoked the Emergency Use Authorization (EUA) authorizing the use of an unapproved product or an unapproved use of an approved product, provided that other statutory criteria are met.

In the European Union, Article 59 of the EU MDR (2017/745) can be used where the European Commission is responsible for identifying and authorizing certain medical devices and PPE that may be sold without CE Marking during the public health emergency and market access is granted individually by the Competent Authority of each member state. The EU has already issued an implementing act restricting export of PPE from the EU  and recommended conformity assessment procedures within the context of COVID-19 threat, including extraordinary measures related to notified body audits.

In this show, we’ll discuss both emergency applications and talk with experts on:

Does your organization have a product that could utilize these pathways? Do you have questions on how to get this done quickly and effectively? 

Panelists:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

This is the audio-only version of DEVICE LOVE Live! #1, originally recorded April 17th, 2020.

The medical device industry’s reliance on China for suppliers, manufacturing sites, and finished medical devices is widespread and well understood. In 2019, the U.S. President leveraged the “International Emergency Economic Powers Act (IEEPA)” in an effort to urge United States companies to begin searching for production alternatives outside of China. The act authorizes the President to regulate foreign economic transactions when a national emergency is declared to manage any unusual and extraordinary foreign source threat to the U.S.

Fast forward to 2020 and we now know that COVID-19 is magnifying the vulnerability of the U.S. and other countries using China for the production of medical devices. Few could predict that we would be faced with the current struggle to obtain a device as simple, yet critical, as a face mask.

Device manufactures have a good handle on how to relocate manufacturing into China; we’ve all been on at least one of those projects in our careers. But how do we move it back out? What are the obstacles and strategies for success?

In this show, we’ll discuss all of the hurdles you may encounter and talk with experts about strategies to overcome them.

Panelists:

Moderator:

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.