Manage episode 263164069 series 2688337
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 the early years on the market. The risk files for these devices may be thin, and far from compliant to the EU MDR. As an added complication, in the intervening years the Risk Management Standard ISO-14971:2019 has also gone thru a revision. This is the current “State-of-Art” standard referenced for the Risk Management section of the MDR. These changes must also be considered when revising legacy Risk Management Files.
What are some efficient approaches to getting these files audit-ready?
What are the expectations of the notified bodies?
We cover these questions and much more in this Live! session.
- Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
- Nancy Morrison — Executive Director of Regulatory and Quality Consulting Services, R&Q
- Steve Keverline - Vice President of Consulting Operations, R&Q
- Tim Connor - Principal Engineer, R&Q
- 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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