LTR 164: Susan Neadle on Combination Device Risk Management

Podcast: Let's Talk Risk! Podcast · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Opublikowano: 2026-10-02

Summary “ISO 14971 and ICH Q9 are not competing frameworks. They are asking different questions about risk.” In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Susan Neadle, Principal Consultant and President of Combination Products Consulting Services, to explore what changes when medical device and pharmaceutical risk-management approaches come together in a combination product. ISO 14971 places strong emphasis on hazards, hazardous situations, harms, users, and safety. ICH Q9 approaches risk through a different lens, with a strong focus on product quality, process variability, critical quality attributes, and control strate...