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FDA 101: Audits, Classification Rules and EU MDR artwork
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FDA 101: Audits, Classification Rules and EU MDR

RA/QA Today by RAQA Today

Sep 15, 202500:27:51Business

In this episode of Device and Conquer , we unpack the differences between the FDA’s inspection style and the EU’s notified body-driven approach. From classification rules and audit methodologies (QSR, ISO 13485, MDSAP) t...

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FDA 101: Audits, Classification Rules and EU MDR is an episode from RA/QA Today by RAQA Today. In this episode of Device and Conquer , we unpack the differences between the FDA’s inspection style and the EU’s notified body-driven approach....

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Published Sep 15, 2025, 00:27:51 long, audio available.

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