Risk Controls Make Your Life Easier (Medical Device Risk Management)
Dr. Oliver Eidel
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ISO 14971: Medical Device Risk Management
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Updated November 26, 2025
What do you do if a risk is not acceptable in your risk analysis? Easy - just randomly change your probabilities. Just kidding. The correct answer, of course, is to consider risk controls and add them to your medical device. That's exactly what we'll be doing in this video, with the goal of further completing our ISO 14971 - compliant risk analysis of our medical device.
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
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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!
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!
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