Don't know where to start? Watch our free starter videos and save lots of time and consultant fees

Articles Technical Documentation

Updated November 22, 2022

IEC 62304

Dr. Oliver Eidel

The IEC 62304 describes how to develop and document software for medical devices. This page contains all our articles we’ve posted so far on this standard, plus questions we’ve been asked by our consulting clients. Additionally, we publish our IEC 62304 templates for free (yes, seriously) and you can also find those below.

IEC 62304 Templates

We’ve published all our IEC 62304 templates for free, no strings attached! Take a look :)

Questions Other Companies Ask Us About IEC 62304

Do We Have to Re-Do All Software System Tests After a Minor Change?
Can We Use GitHub and Other SaaS For Our Software as a Medical Device?
Should You Automate Your Software Architecture Documentation?
Do Auditors Read Your Code?
How to document SOUP for IEC 62304 compliance?

All IEC 62304 Articles

Doing a Software Release in Compliance With IEC 62304
Software System Testing Based on the IEC 62304
Medical Device Software Architecture Documentation (IEC 62304)
Software Verification For Medical Device Software (IEC 62304)
Writing Software Requirements Based on the IEC 62304
Writing a Software Development and Maintenance Plan for IEC 62304 Compliance
IEC 62304 Walkthrough

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!

No QMS on this planet will save you from creating crappy software.