Document and Record Control For Medical Device Quality Management Systems (ISO 13485 QMS)

Dr. Oliver Eidel · Clinical Evaluation · Published September 08, 2022
It's important to define how you handle your documents and records. Sounds weird, but it's actually quite easy! This is important, because you need these procedures to be compliant with the ISO 13485 which is required for medical device manufacturers.

This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information:
https://openregulatory.com/courses/the-wizard/
Dr. Oliver Eidel

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!
More about me

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

No comments yet. Be the first to share your thoughts.