Writing Software Requirements For IEC 62304 Compliance
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 Choosing an example: MindDoc
01:45 Documenting software requirements with a template (terrible)
05:24 A better way (Formwork eQMS)
09:39 Adding another system and software requirement
11:35 Understanding relations and creating a user need
14:25 Versioning
15:39 Creating another software requirement
16:50 Creating a Stakeholder
17:35 The requirements overview
18:36 The magical audit export
20:25 Don't over-engineer
From the perspective of regulators, software is developed not by writing code, but by sitting in a dark room, smoking cigars and writing software requirements. This is not necessarily close to reality in 2025, but we will still go ahead and write software requirements, because that's what the IEC 62304 wants us to do.
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
01:45 Documenting software requirements with a template (terrible)
05:24 A better way (Formwork eQMS)
09:39 Adding another system and software requirement
11:35 Understanding relations and creating a user need
14:25 Versioning
15:39 Creating another software requirement
16:50 Creating a Stakeholder
17:35 The requirements overview
18:36 The magical audit export
20:25 Don't over-engineer
From the perspective of regulators, software is developed not by writing code, but by sitting in a dark room, smoking cigars and writing software requirements. This is not necessarily close to reality in 2025, but we will still go ahead and write software requirements, because that's what the IEC 62304 wants us to do.
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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