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)