Usability Evaluation Plan & Report (Finalizing Medical Device Usability Compliance - IEC 62366)

Dr. Oliver Eidel · IEC 62366: Medical Device Usability Engineering · Updated November 26, 2025
We're 95% done with our usability compliance documentation for our medical device. Now we just need to wrap up the missing pieces which mostly boils down to the bureaucratic busywork of filling out rich-text document templates to make our auditors happy. I'll walk you through filling out the so-called usability evaluation plan and report.

00:00 Introduction & recap
01:22 Copying over usability evaluation templates
02:42 Usability evaluation plan walkthrough
05:21 Usability evaluation report walkthrough
06:58 Audit export
09:41 Usability course wrap-up

The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
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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