Documenting Failure Modes 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
What could possibly go wrong in our software?
We'll learn about software failure modes in the context of a FMEA:
- How to associate Failure Modes with software systems
- How to link up Failure modes with the Hazards in our FMEA and analyze them further.
Here's 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.
We'll learn about software failure modes in the context of a FMEA:
- How to associate Failure Modes with software systems
- How to link up Failure modes with the Hazards in our FMEA and analyze them further.
Here's 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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