Hardware Podcasts

#422: ISO 14971 and the Road to Risk Management with Edwin Bills

Global Medical Device Podcast · 1 Sept 2025 · 1h 03m · Episode 422

What this episode covers

Edwin Bills, a lead expert in medical device risk management and key contributor to ISO 14971, explains how his background as a submariner and manufacturing quality engineer informs his approach to patient safety and cost of quality. He details the critical link between manufacturing process capability (CPK), supplier quality, and financial risk, arguing that quality failures directly impact a company's bottom line and reputation. Bills critiques common industry practices, such as late-stage FMEA and manual spreadsheet-based traceability, advocating for early hazard analysis, industrial statistics, and integrated software solutions to manage complex risks in medical devices and combination products.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Cincinnati Millicron, Motorola, Toyota, Abbott, AAMI
Materials
HY 80 steel
Also
ISO 14971, IEC 60601, FDA, FMEA, PHA

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