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 e...
Jun 03, 2021•43 min•Transcript available on Metacast 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 por...
May 20, 2021•45 min•Transcript available on Metacast 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: Minimize questions Minimize deficiencies Achieve certification 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 obvio...
May 06, 2021•55 min•Transcript available on Metacast 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: What types of clinical evidence gaps are notified bodies citing? What are some solutions to enable keeping your devices on the market? ...
Apr 23, 2021•52 min•Transcript available on Metacast 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: No, you should not reclassify all of your Class I devices to Class Ir to gain extra time; classifications need to be done corre...
Apr 08, 2021•49 min•Transcript available on Metacast 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...
Mar 26, 2021•52 min•Transcript available on Metacast 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...
Mar 11, 2021•37 min•Transcript available on Metacast 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 ...
Feb 25, 2021•49 min•Transcript available on Metacast 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 ta...
Feb 12, 2021•57 min•Transcript available on Metacast This is the audio-only version of DEVICE LOVE Live! #27 , originally recorded January 28, 2021. Were 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 representati...
Jan 28, 2021•42 min•Transcript available on Metacast This is the audio-only version of DEVICE LOVE Live! #26 , originally recorded January 14, 2021. In this unique episode of DEVICE LVE 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!...
Jan 15, 2021•36 min•Transcript available on Metacast 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 LVE Live! show, our expert panelists will discuss the following and more:...
Dec 21, 2020•38 min•Transcript available on Metacast 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 te...
Dec 04, 2020•33 min•Transcript available on Metacast 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 &nb...
Nov 24, 2020•38 min•Transcript available on Metacast 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 201...
Nov 06, 2020•37 min•Transcript available on Metacast 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: ...
Oct 23, 2020•41 min•Transcript available on Metacast 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 UKs position and stated reversal on EU MDR/EU IVDR, and the expected timelines and grace periods ...
Oct 12, 2020•26 min•Transcript available on Metacast 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. Will what I have be enough or am I planning for too much? How do I get the functions aligned... PMS, Regulatory, Risk, Clinical, Marketing? It's not easy! In this show we'll answer popular questions from ou...
Sep 29, 2020•33 min•Transcript available on Metacast 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 oth...
Sep 11, 2020•40 min•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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 o...
Jun 04, 2020•32 min•Transcript available on Metacast 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•Transcript available on Metacast 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 industryor 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 and IVDR Consu...
May 22, 2020•47 min•Transcript available on Metacast 
