Hardware Podcasts

For the Love of Internal Auditing

Global Medical Device Podcast · 26 Apr 2021 · 33m · Episode 199

What this episode covers

Jon Speer, founder of Greenlight Guru, interviews Sara Adams, a medical device guru at Greenlight Guru, about the strategic value of internal auditing in medical device quality systems. They discuss shifting from checkbox compliance to risk-based auditing, debunking misconceptions that every finding requires a CAPA or that all processes must be audited annually. The conversation highlights the importance of planning, cross-functional collaboration, and using electronic QMS platforms like Greenlight Guru to streamline audits and improve regulatory readiness.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru
Also
ISO 13485:2016, FDA, MDSAP

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