ISO 14971 Templates

ISO 14971 is the standard for risk management of medical device software. Here are all our posts on this standard, and also all questions our consulting clients have asked us about the ISO 14971 so far. Additionally, we publish all our document templates for the ISO 14971 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 ISO 14971 templates for free! Check them out below.

Also note that we have many more templates besides the ones for this ISO standard – 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.