Hardware Podcasts

#326 CSA vs. CSV: Modern Validation for Modern MedTech

Global Medical Device Podcast · 7 Jul 2023 · 1h 08m · Episode 326

What this episode covers

Sandra Rodriguez, an analyst at Axendia, discusses the FDA's shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) in medical device manufacturing. She explains how CSA flips the traditional validation pyramid by prioritizing critical thinking and risk assessment over exhaustive documentation, significantly reducing the burden on companies. The conversation covers the industry's response to the September 2022 draft guidance, the role of GAMP 5, and the evolving relationship between life science companies and technology vendors like Greenlight Guru.

Most relevant to

established companies

Topics

Mentioned

Companies
Axendia, Greenlight Guru, FDA, Boston Scientific, Edwards Life Sciences, Baxter, MDIC
Also
GAMP 5, Case for Quality, ISO 13485, ISO 14971, 21 CFR Part 11

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