Hardware Podcasts

Human Factors & Risk Management: What's Needed & Why?

Global Medical Device Podcast · 2 Mar 2022 · 40m · Episode 248

What this episode covers

Shannon Hoste, President of Agilis Consulting Group and former lead of the FDA’s Human Factors Team, explains how human factors serves as a critical risk management activity for medical device development. She details the importance of the Use-Related Risk Assessment (URRA) in identifying potential use errors and high-disparity harms early in the design process to ensure safe and effective product use. Hoste discusses the evolution of ISO 62366, the challenges engineers face in understanding qualitative user needs, and the necessity of integrating human factors into the product development lifecycle rather than treating it as a late-stage compliance checkbox.

Most relevant to

established companies

Topics

Mentioned

Companies
Agilis Consulting Group, FDA, Green Light Guru, Pathway for Patient Health
Tools
DOORS
Also
ISO 62366

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