Internal Audit For Medical Device Manufacturers (ISO 13485 Compliance)

Dr. Oliver Eidel · Clinical Evaluation · Updated August 11, 2026
Doing regular internal audits is another requirement of the ISO 13485. You might think that this is over-engineered, especially for startups. Let's just say you're not alone.

This video is part of our free medical device compliance library. Browse all videos on our website, watch them on the OpenRegulatory YouTube channel, or follow the courses inside Formwork.
Dr. Oliver Eidel

Dr. Oliver Eidel

I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.

Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you’re still lost and have further questions, reach out any time!
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