ISO 14971 is the standard for risk management of medical device software. This page is a collection of all our articles on risk management. We also publish all our document templates for the ISO 14971 for free and you can find them below!
ISO 14971 Templates
We’ve published all our ISO 14971 templates for free, no strings attached! Take a look 🙂
All ISO 14971 Articles
FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)
ISO 14971 Walkthrough
On a different note: Do you need any help with your EU MDR efforts?
We’ve worked with 100+ companies and helped them certify their devices in weeks, not months. Talk to us now – first calls are free! Check out our services and prices here.
Or, if you don’t like talking to humans, check out our Wizard instead. It’s a foolproof, step-by-step video course for getting your compliance done yourself.
And if you’re looking for the best QMS software for lean, founder-led companies, check out Formwork. It automates your compliance, and there’s even a free version for you to try out!