Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View


Manage episode 284649992 series 1017311
By Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory, Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, and Consultants; R. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.
Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the recommended guidelines is one of the most important things a medical device company can do to be successful. In this episode of the Global Medical Device Podcast, Jon Speer talks to Ed Bills, risk management consultant and technical committee member of the working group for ISO 14971:2019 and ISO TR 24971:2020, who shares key insights from his work developing the latest version of the international risk standard and offers recommendations for companies that will help strengthen their product risk management practices.

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