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IEC 62304

Dr. Oliver Eidel • Uncategorized • Updated October 01, 2024
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

All IEC 62304 Articles

On a different note: Do you need any help with your EU MDR efforts?

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Dr. Oliver Eidel

IEC 62366

Dr. Oliver Eidel
updated 9 months ago
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Dr. Oliver Eidel

IEC 62304 Walkthrough

Dr. Oliver Eidel
updated 9 months ago
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IEC 82304: How Is It Different From The IEC 62304?

Anonymous
updated 7 months ago
We're just getting started with our medical device documentation, and we initially thought that we need to comply with the IEC 62304 regarding our software documentation. Now, someone mentioned the IE
Dr. Oliver Eidel

Accepted answer

Don't worry about it. Auditors won't like me for saying this, but the 82304 doesn't contain much additional content on top of the 62304. Just comply w

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Dr. Oliver Eidel avatar

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!
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