The IEC 62304 describes how to develop and document software for medical devices.
IEC 62304 Templates
We’ve published all our IEC 62304 templates for free, no strings attached! Take a look :)
Articles Technical Documentation
Updated August 3, 2022
IEC 62304
Dr. Oliver Eidel
On a slightly different note: Did you know that we also provide consulting, often guiding startups from start to finish in their medical device compliance?
And there's so much more: If you're looking for the best QMS software ever, look no further. We've built Formwork, and it's free!
If you're interested in watching me write documentation for a medical device, check out our screencasts. And finally, there's our free Slack community with 500+ people from medical device companies in which people help each other out by answering questions. You should check it out! :)
Congratulations! You read this far.
Get notified when we post something new.
Sign up for our free newsletter.
Dr. Oliver Eidel
I'm a medical doctor, software engineer and regulatory dude. I've helped 50+ companies with their medical device compliance. I mainly work as a regulatory consultant, but my goal is to make consulting unnecessary by publishing all of our articles and templates for free :)
If you're still lost and have further questions, just send me an email. Read more about me here.