Live! #10 — Transition to IVDR: How far along should we be?

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 expectations of much tighter controls over the web of virtual manufacturing and distribution relationships IVD companies are accustomed to.

This panel will discuss the following and more:

How far along should IVD companies should be in the transition process? What are good milestones to set for 2020 and 2021? With limited resources, where should you focus? Where do you start with economic operators? What does compliance or "good" look like and how do you align on that with your notified body... when at this point, only a few notified bodies are designated?

The panel is stacked with former notified body representatives and experienced R&Q subject matter experts:

Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q Ibim Tariah, Ph.D. — VP of EU MDR/IVDR Consulting Services, R&Q (former BSI) Ron Sills — Principal Specialist, R&Q (former TUV Rheinland) Justin DiValentino — Principal Specialist, R&Q

Moderator:

Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.