Understanding the IEC 62304 Safety Classes and the Mysterious V-Model
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 Documentation differences for 62304 safety classes
01:19 Determining your 62304 safety class
05:18 Understanding the V-Model
The most important starting point for your IEC 62304 compliance is your 62304 software safety classification. Depending on whether your software is A, B or C, you have to fulfill difference documentation requirements.
We'll take a look at how to classify your software here.
After that, we'll attempt to understand the V-model of software development. This is a way of developing software which regulators came up with and is completely detached from reality.
Check out our website https://openregulatory.com for more!
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
01:19 Determining your 62304 safety class
05:18 Understanding the V-Model
The most important starting point for your IEC 62304 compliance is your 62304 software safety classification. Depending on whether your software is A, B or C, you have to fulfill difference documentation requirements.
We'll take a look at how to classify your software here.
After that, we'll attempt to understand the V-model of software development. This is a way of developing software which regulators came up with and is completely detached from reality.
Check out our website https://openregulatory.com for more!
The software I'm using in the video is Formwork, our eQMS software. Check it out 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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