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: Is the bio...
Jan 06, 2022•50 min
The RQM+ team has collected PMCF data from surveys on thousands of patients and charts on hundreds of devices, and we're excited to share our case studies. In this Live! show we will dive into our PMCF survey successes and discuss the ways that surveys have significantly helped manufacturers maintain label indications by providing a process for collecting data to support all claims, indications, and user populations. The survey approach has saved our clients significant amounts of money (in the ...
Dec 03, 2021•50 min
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 positi...
Nov 11, 2021•54 min
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 ple...
Oct 15, 2021•51 min
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 argume...
Oct 01, 2021•39 min
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 requirem...
Aug 27, 2021•45 min
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 learne...
Jul 23, 2021•40 min
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 targe...
Jun 18, 2021•39 min
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 ...
Jun 09, 2021•52 min
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
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
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
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
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
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 equivale...
Mar 26, 2021•52 min
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
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 documentatio...
Feb 25, 2021•49 min
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
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 representat...
Jan 28, 2021•42 min
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 belo...
Jan 15, 2021•36 min
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 mor...
Dec 21, 2020•38 min
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
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
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
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
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 period...
Oct 12, 2020•26 min
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
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
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
