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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 WET and non-WET devices. Even with this guidance, we're still seeing debate between device companies and their notified bodies on what is classified as WET.
In this show, we'll provide our current thinking on this debate and some tips for interacting with your notified body.
Here's the panel:
Ibim Tariah, Ph.D. — VP of EU MDR and IVDR Consulting Services (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI) Nancy Morrison, RAC — Executive Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q Jon Gimbel, Ph.D. — Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team Ron Sills — Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
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.
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