Hardware Podcasts

025 - “The Frying Pan to the Fire” with Edwin Bills

Let's Combinate · 23 Mar 2022 · 1h 31m

What this episode covers

Edwin Bills, a Risk Management Expert and former committee member for ISO 14971, ISO TR 24971, and AAMI TIR 105, explains the evolution of risk management standards in medical devices and combination products. He details the philosophical differences between ISO 14971 and ICH Q9, emphasizing that risk management must focus on patient safety rather than just regulatory compliance. Bills advises engineers to use qualitative methods early in development and highlights the importance of analyzing interactions between drug and device constituents in combination products. He also discusses the expanded requirements for post-market surveillance in the 2019 standard and the upcoming harmonization of ISO 14971 in Europe.

Most relevant to

established companies

Topics

Mentioned

Also
ISO 14971, ISO TR 24971, AAMI TIR 105, ICH Q9, EN 1441, IEC 60601, UL 544, ISO 14155, TR 48, ISO 31000

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