Hardware Podcasts

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

Global Medical Device Podcast · 10 Feb 2021 · 40m · Episode 179

What this episode covers

Ed Bills, a risk management consultant and technical committee member for ISO 14971:2019 and ISO TR 24971:2020, joins host Jon Speer to explain the nuances of the updated international medical device risk management standards. They discuss the separation of guidance from requirements, the critical role of post-market surveillance in Clause 10, and the regulatory landscape involving the EU MDR and IVDR. Bills emphasizes that risk management is a product safety standard distinct from business or project risk, and advises companies to read the full rationale and technical report to avoid common misinterpretations.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, FDA, BSI, GHTF
Also
ISO 14971:2019, ISO TR 24971:2020, EU MDR, EU IVDR, IEC 60601, ISO 13485

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