Hardware Podcasts

#325 The Role of dFMEAs in Risk Management for Medical Devices

Global Medical Device Podcast · 30 Jun 2023 · 36m · Episode 325

What this episode covers

Wade Schroeder, a medical device expert at Greenlight Guru, explains how dFMEA and ISO 14971 work together to manage risk in medical device design. He argues that while dFMEA provides a useful bottom-up technical view, ISO 14971 offers a necessary top-down, patient-focused strategy that maps directly to FDA expectations. Schroeder highlights Greenlight Guru’s software as a tool that integrates risk management with design controls, reducing the complexity of maintaining separate systems. The discussion emphasizes using tools like fault tree analysis and fishbone diagrams to ensure comprehensive safety without compromising regulatory compliance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Products
Greenlight Guru Risk Intelligence
Also
ISO 14971, dFMEA, FDA

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