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.
And finally, do you want to draft your own QMS with just one click? With Formwork, our eQMS software, combined with our free templates and a little bit of ChatGPT magic, you can draft your QMS in minutes. Check out the video below to see how it works.