September 23-25, 2019 — Boston, MA
In addition to exhibiting in booth #347 at this year's MedTech Conference (powered by AdvaMed) in Boston, MA, we've recently been confirmed for a thrilling panel discussion related to CERs that we cannot wait to participate in. As excited as we are for our panel discussion (and more) at this year's RAPS Regulatory Convergence, this AdvaMed session is right up there with it. It's fitting The MedTech Conference's slogan is Improving Health Care. Improving Lives. Improving people's lives is exactly the R&Q mission.
R&Q Executive Director and CER Business Unit Lead, Jon Gimbel, will be sharing his extensive CER experiences and leadership in the panel discussion One Year In: What We’ve Learned from Creating 100's of MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs (It’s Harder Than You Think). The session is scheduled for Wednesday, September 25th from 8:45-9:45am.
Here's the current lineup of accomplished panelists:
― Ibim Tariah, Ph.D. – Vice President of EU MDR and IVDR Consulting Services, Regulatory & Quality Solutions (R&Q)
― Jon Gimbel, Ph.D. – Executive Director and CER Business Unit Lead, Regulatory & Quality Solutions (R&Q)
― Dona Occhipinti, MPH, CCRP – Corporate EU MDR Clinical Evaluation Lead, Hillrom
What will be discussed?
MEDDEV 2.7/1 Rev. 4 is mandatory and EU MDR is right around the corner. Notified bodies are scrutinizing clinical data more than ever and giving companies significant findings for their CERs and, in some cases, refusing to certify products with gaps in clinical evidence, incomplete PMCF, and poorly written CERs. Attendees will come away with an understanding of the latest developments in CERs based on real-life stories. These are case studies you’ll want to hear.
This session will feature medical device manufacturers and device consultants who have created Rev. 4 and MDR compliant CERs for products in a wide range of clinical specialties - being submitted to notified bodies. Our panel has seen it all and will share the most impactful lessons learned from every aspect of the CER process.
Our speakers have encountered plenty of obstacles…and found solutions. In this session, learn how other manufacturers and experts have addressed closing their CER gaps and achieving compliance. Attendees can take these lessons back to your companies to gather the support needed to get your CERs ready.
Industry leaders will discuss lessons learned and case studies featuring a multitude of challenges. For example:
― What is the difference between a Rev 4 and MDR complaint CER?
― Notified Bodies will review your submission as if it is the first time; what does that mean?
― What are you options if you have a low-risk device with no clinical data?
― How are notified bodies reviewing CERs? What questions are they asking and what are they looking for in the clinical data?
― When do you need to propose pro-active PMS or PMCF?
If you're in Boston for this event we hope you'll listen to and ask questions at our panel discussion. Part of our subject matter experts' responsibilities include sharing their experiences with industry and answering your questions at events just like. We hope you'll take advantage. More information on the conference can be seen here.
An important related note: Are you signed up for R&Q's free CER Virtual Workshop on September 12th? If you have even the slightest interest in the above panel discussion, you won't want to miss this free event you can consume and participate in from your couch. Sign up here.