Episode 90 | Kyle Rose: President at Rook Quality Systems | FDA's ISO 13485 Transition Plan...What Does it Mean for Your Medtech's Quality Plan?


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  • In this episode, Kyle Rose from Rook Quality Systems and Duane Mancini discussthe FDA’s ISO-13485 transition plan, when it was announced, what it looks like, the differences 21 CFR Part 820 vs. ISO 13485, the importance of a risk based approach in quality, updates on the MDR and current trends, could the FDA move towards requiring more clinical data from medical device manufacturers, if regulatory and quality were the only factors in determining your global get-to-market strategy…where would you go, and so much more.
  • Kyle Rose LinkedIn
  • Rook Quality System Website
  • Project Medtech Website
  • Duane Mancini LinkedIn
  • Project Medtech LinkedIn

156 episodes