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 ISO 14971 - head over to our templates page for more templates.