Updated March 16, 2023

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

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I've helped 50+ companies with their medical device compliance. I mainly work as a regulatory consultant, but my goal is to make consulting unnecessary by publishing all of our articles and templates for free :)

If you're still lost and have further questions, just send me an email. Read more about me here.

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