Writing a Software Development and Maintenance Plan 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 Regulators have weird ideas
01:12 Looking at the template
01:45 Creating it in Formwork
03:55 Filling out the software development plan
08:50 Saving it and versioning
Another requirement of the IEC 62304 is that you "plan" your development. The typical way to comply with this is by writing a Software Development and Maintenance Plan. Suffice to say, it's not the most interesting activity, but I'll show you how to do it in this video.
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
01:12 Looking at the template
01:45 Creating it in Formwork
03:55 Filling out the software development plan
08:50 Saving it and versioning
Another requirement of the IEC 62304 is that you "plan" your development. The typical way to comply with this is by writing a Software Development and Maintenance Plan. Suffice to say, it's not the most interesting activity, but I'll show you how to do it in this video.
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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