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Templates

Updated November 22, 2022

IEC 62366 Templates

Dr. Oliver Eidel

The IEC 62366 is about usability of medical device software. In practice, it’s mostly about running usability tests with users. Here are all our posts on this standard, and also all questions our consulting clients have asked us about the IEC 62366 so far. Additionally, we publish all our document templates for the IEC 62366 for free, so scroll down and have a look at those! If you fill those out, you have a good chance of already being compliant with the standard, no consultants required :)

The best news is that we’ve published all our IEC 62366 templates for free! Check them out below.

Also note that we have many more templates besides the ones for IEC 62366 - head over to our templates page for more templates.

All IEC 62366 Templates

Template: IEC 62366-1:2015 Mapping of Requirements to Documents
Template: Usability Evaluation Report
Template: Usability Evaluation Protocol
Template: Usability Evaluation Plan
Template: List of Hazard-Related Use Scenarios

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.

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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.