Rqm public
[search 0]
More

Download the App!

show episodes
 
RQM+ industry-leading experts discuss regulatory and quality challenges medical device and diagnostic companies are facing. 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 deliv ...
 
Loading …
show series
 
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 season…
 
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 que…
 
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. Ho…
 
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 the…
 
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…
 
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 te…
 
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 secon…
 
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 tim…
 
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…
 
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 follow…
 
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. He…
 
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, includi…
 
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 manuf…
 
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 Directive…
 
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 …
 
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 expe…
 
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, includin…
 
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 …
 
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 s…
 
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 addit…
 
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 pub…
 
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 “enoug…
 
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…
 
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?…
 
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 comprehensiv…
 
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 dis…
 
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 (former…
 
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-…
 
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 cross…
 
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…
 
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…
 
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 r…
 
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, ref…
 
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 – …
 
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 …
 
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…
 
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…
 
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…
 
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 prod…
 
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 appr…
 
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…
 
Loading …

Quick Reference Guide

Copyright 2021 | Sitemap | Privacy Policy | Terms of Service
Google login Twitter login Classic login