Failure Mode and Effects Analysis (FMEA) for ISO 14971 (Risk Management For Medical Devices)
Dr. Oliver Eidel
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Clinical Evaluation
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Updated August 11, 2026
We'll attempt to transform our freestyle simple Risk Table to a full-blown FMEA.
Along the way, we'll be learning about:
- Understanding Hazards, Hazardous Situations and Harms
- Understanding intermediate probabilities (p1 and p2) and how to use them
- How to use our Severity Categories
- How to decide whether a risk is acceptable or not
- A Usability Hazard.
Wikipedia article on FMEA with a pretty good explanation and examples:
https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis
Our FMEA template:
https://openregulatory.com/fmea-risk-table-template-iso-14971/
This video is part of our free medical device compliance library. Browse all videos on our website, watch them on the OpenRegulatory YouTube channel, or follow the courses inside Formwork.
Along the way, we'll be learning about:
- Understanding Hazards, Hazardous Situations and Harms
- Understanding intermediate probabilities (p1 and p2) and how to use them
- How to use our Severity Categories
- How to decide whether a risk is acceptable or not
- A Usability Hazard.
Wikipedia article on FMEA with a pretty good explanation and examples:
https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis
Our FMEA template:
https://openregulatory.com/fmea-risk-table-template-iso-14971/
This video is part of our free medical device compliance library. Browse all videos on our website, watch them on the OpenRegulatory YouTube channel, or follow the courses inside Formwork.
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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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