Documenting Failure Modes for ISO 14971 (Risk Management For Medical Devices)
Dr. Oliver Eidel
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Clinical Evaluation
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Published May 09, 2021
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 is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information:
https://openregulatory.com/courses/the-wizard/
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 is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information:
https://openregulatory.com/courses/the-wizard/
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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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