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Articles Quality Management

Updated November 22, 2022

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

ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes
CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?

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.

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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.