IEC 62304

Dr. Oliver Eidel
Updated October 1, 2024
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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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