Don't know where to start? Watch our free starter videos and save lots of time and consultant fees

Articles Technical Documentation

Updated November 22, 2022

IEC 62366

Dr. Oliver Eidel

The IEC 62366 is about usability of medical device software. In practice, it’s mostly about running usability tests with users. This page is a collection of all our articles on this usability standard. We also publish all our document templates for the IEC 62366 for free and you can find them below!

IEC 62366 Templates

We’ve published all our IEC 62366 templates for free, no strings attached! Take a look :)

Questions Other Companies Ask Us About IEC 62366

Do You Need Video Cameras For User Testing?
What's the Minimum Number of Users for a Usability Test?

All IEC 62366 Articles

How To Do a Summative Usability Evaluation For IEC 62366 Compliance
The IEC 62366 (Usability) Summary: All You Need To Know (It's Not Much)

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

Congratulations! You read this far.

Get notified when we post something new.

Sign up for our free newsletter.

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!

No QMS on this planet will save you from creating crappy software.