Hardware Podcasts

161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products

Let's Combinate · 6 Nov 2024 · 24m

What this episode covers

Host Subhi Saadeh explains the distinct yet complementary roles of ISO 14971 and ICH Q9 in managing risk for combination products, highlighting how ISO 14971 focuses on patient safety through lifecycle management while ICH Q9 addresses broader pharmaceutical quality risks. He details the recent updates in ICH Q9 R1, particularly regarding managing subjectivity and scaling formality, and contrasts the structured, plan-driven approach of device risk management with the more collaborative, problem-driven nature of pharma risk assessments. Saadeh emphasizes critical concepts unique to ISO 14971, such as 'state of the art' for residual risk evaluation and the dual verification of implementation and effectiveness, which are essential for ensuring safety in complex drug-device combinations.

Most relevant to

established companies

Topics

Mentioned

Also
ISO 14971, ICH Q9, ICH Q9 R1, ISO 13485, QMSR, FMEA, HACCP, ASTM Committee E55, Combination Products Coalition, AAMI

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