Failure Mode and Effects Analysis (FMEA) for ISO 14971 (Risk Management For Medical Devices)
Dr. Oliver Eidel
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Clinical Evaluation
·
Published May 09, 2021
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 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/
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 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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