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FDA 101: Audits, Classification Rules and EU MDR
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...
About This Episode
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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Episode Details
Published Sep 15, 2025, 00:27:51 long, audio available.
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Questions About This Episode
What is FDA 101: Audits, Classification Rules and EU MDR about?
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) to unannounced FDA inspections versus Europe’s annual surveillance audits, we dig into what medical device companies really need to know before entering either market. Whether you’re a startup navigating your first clearance or a seasoned RA/QA pro, this is your crash course on how regulators (and auditors) think—and why it matters for your compliance strategy. Watch the video version on YouTube:
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Which podcast is FDA 101: Audits, Classification Rules and EU MDR from?
FDA 101: Audits, Classification Rules and EU MDR is an episode from RA/QA Today by RAQA Today.
How long is this episode?
This episode is 00:27:51 long.
When was this episode published?
This episode was published on Sep 15, 2025.
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Are there related episodes from RA/QA Today?
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Where can I listen to FDA 101: Audits, Classification Rules and EU MDR?
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Which podcast is this episode from?
FDA 101: Audits, Classification Rules and EU MDR is from RA/QA Today by RAQA Today.
What are the episode details?
Published Sep 15, 2025 and 00:27:51 long