AI QMS: Where ChatGPT Fails (Cybersecurity Requirements)

Dr. Oliver Eidel · AI For Medical Device Compliance · Updated November 26, 2025
Where does AI fail for medical device QMS writing? Let's take a look at one example where you still need real humans to edit QMS documents, chuckle..

00:00 Introduction
01:08 Shady IEC sales page
01:32 Editing SOP with AI
04:45 Fails

By the way, even though it didn't work out too great in this video (haha), the chat-based rewriting eQMS feature is available right now on all our plans, including our free plan! For even more AI features, upgrade to one of our paid plans starting at only 99€ / month.

If you're interested, check out our QMS software, Formwork:
https://openregulatory.com/

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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!
More about me

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