No One Does Preliminary Hazards Analysis (Mostly) (ISO 14971 Medical Device Risk Analysis)
Dr. Oliver Eidel
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ISO 14971: Medical Device Risk Management
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Updated November 26, 2025
Theoretically, the ISO 14971 requires you do do a preliminary hazards analysis (PHA) as part of your medical device risk analysis. The reality is that companies tend to "forget" about this and do it later. And that's fine, as long as you do it - your documentation will be complete, and your auditor will be happy.
Accordingly, in this video, I'll show you how to do a preliminary hazards analysis (minimalistic approach, as always).
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/
Accordingly, in this video, I'll show you how to do a preliminary hazards analysis (minimalistic approach, as always).
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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ISO 14971 Walkthrough
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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!
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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