Employee QMS Training For ISO 13485 Compliance, Using eQMS Software

Dr. Oliver Eidel · Clinical Evaluation · Published May 24, 2022
One requirement of the ISO 13485 for quality management is that you have to prove that all people in your organisation (employees etc.) have been trained on your internal procedures.

Without software, this is a huge pain because you have to manually do training sessions with everyone (in person or remote), and then you have to collect signatures from all attendees (again, remotely or in person).

eQMS software offers a lot of potential for automation in this area - you can literally perform compliant trainings in seconds, and not hours. Check it out!

Are you interested in shipping your medical software faster? Check out Formwork:
https://openregulatory.com/
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

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