Formative Evaluation For Usability Compliance (IEC 62366 For Medical Devices)

Dr. Oliver Eidel · IEC 62366: Medical Device Usability Engineering · Updated November 26, 2025
Besides doing a summative evaluation, the IEC 62366 (the standard for usability engineering for medical devices) also mentions something called a "formative evaluation". It's optional, but it's useful. I'll show you an example of a formative evaluation and how you can document it in an efficient way.

00:00 Introduction
02:40 Doing an example formative evaluation

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

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

No comments yet. Be the first to share your thoughts.