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 eff...
Sep 11, 2020•40 min
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 follow...
Aug 31, 2020•40 min
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 al...
Aug 14, 2020•33 min
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 W...
Jul 31, 2020•33 min
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 ke...
Jul 17, 2020•25 min
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: Content ...
Jul 06, 2020•45 min
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, espe...
Jun 25, 2020•43 min
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 exp...
Jun 18, 2020•34 min
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 recom...
Jun 11, 2020•24 min
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 m...
Jun 04, 2020•32 min
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 i...
May 28, 2020•39 min
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: Ibim Tariah, Ph.D. — Vice President of EU MDR a...
May 22, 2020•47 min
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: Ibim Tariah, Ph.D. — Vice President of EU MDR a...
May 15, 2020•40 min
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, ...
May 12, 2020•38 min
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 recom...
May 12, 2020•40 min
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 Comm...
May 12, 2020•30 min
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 foreig...
May 12, 2020•36 min
