Articles Quality Management

Updated March 16, 2023

ISO 13485

Dr. Oliver Eidel

The ISO 13485 is the standard for quality management in the medical device industry. This page is a collection of all our articles on this quality management standard. We also publish all our document templates for the ISO 13485 for free and you can find them below!

ISO 13485 Templates

We’ve published all our ISO 13485 templates for free, no strings attached! Take a look :)

Questions Other Companies Ask Us About ISO 13485

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?
Software Validation Procedure for ISO 13485 compliance?

All ISO 13485 Articles

CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?

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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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