Software Release and Review: Final Tasks For IEC 62304 Compliance For Software as Medical Device
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 We're not done?
00:59 Releasing records
02:50 Stakeholder documentation
04:20 Actually fixing the stakeholder
06:53 Adding software tests
07:58 Adding software test runs
09:10 Adding user tests
12:01 Reviewing requirements
18:35 Releasing it!
20:10 How do you do it with other software?
Releasing your software as a medical device is probably the biggest step of your medical device (and IEC 62304) compliance journey. Today we're taking it.
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
00:59 Releasing records
02:50 Stakeholder documentation
04:20 Actually fixing the stakeholder
06:53 Adding software tests
07:58 Adding software test runs
09:10 Adding user tests
12:01 Reviewing requirements
18:35 Releasing it!
20:10 How do you do it with other software?
Releasing your software as a medical device is probably the biggest step of your medical device (and IEC 62304) compliance journey. Today we're taking it.
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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