[thi2]

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.