Digital Dinosaurs Supervising Medtech: Getting Audited by the Berlin Authorities

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thi2 · 43m ago

I worked for two years on a medical app. From my limited experience with audits it was more focused on everything being compliant with the ISO 9001 & ISO 13485. Actual tech audits never happend and stuff like Emailing scanned letters never occured. However this was in Hessen and not Berlin.

My point being I guess its ok-ish to not know what software libs are, the paper workflow is still horrible.

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Digital Dinosaurs Supervising Medtech: Getting Audited by the Berlin Authorities

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