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Updated December 2, 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

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Or, if you're looking for some human help, did you know that we also provide consulting, often guiding startups from start to finish in their medical device compliance?

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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.

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