Risk Tables Are Easy (Medical Device Risk Analysis, ISO 14971)
Dr. Oliver Eidel
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ISO 14971: Medical Device Risk Management
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Updated November 26, 2025
Time to create our first risk table entry! What's a risk table, anyway? Luckily, Formwork will guide us in creating the right entries for our risk table - hazards, hazardous situations and harms. All the things we need to perform an ISO 14971 - compliant risk analysis for our medical device!
Technically, what we're doing here is a failure modes and effects analysis (FMEA), but the simple name would just be "risk analysis".
00:00 Introduction
01:14 Recap & risk table
02:44 Defining harms
06:47 Defining hazards & hazardous situations
10:05 Probabilities
11:52 Success, automatic risk matrix look-up
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/
Technically, what we're doing here is a failure modes and effects analysis (FMEA), but the simple name would just be "risk analysis".
00:00 Introduction
01:14 Recap & risk table
02:44 Defining harms
06:47 Defining hazards & hazardous situations
10:05 Probabilities
11:52 Success, automatic risk matrix look-up
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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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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