Software Test Documentation For IEC 62304 Compliance (Medical Device Software)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 Introduction
01:15 Looking into the IEC 62304
03:19 Looking at our templates
08:02 Using our eQMS Formwork
13:21 Can you automate this in your code?
20:44 Did we cover everything?
21:25 Exporting for your audit
In this video, you'll learn how to document your medical device software tests in a IEC 62304 - compliant way. First, we'll look at what sort of documentation auditors expect, then I'll show you how you can automate things and speed them up. Finally, we'll export everything so that you can hand in a neat spreadsheet to your auditors :)
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
01:15 Looking into the IEC 62304
03:19 Looking at our templates
08:02 Using our eQMS Formwork
13:21 Can you automate this in your code?
20:44 Did we cover everything?
21:25 Exporting for your audit
In this video, you'll learn how to document your medical device software tests in a IEC 62304 - compliant way. First, we'll look at what sort of documentation auditors expect, then I'll show you how you can automate things and speed them up. Finally, we'll export everything so that you can hand in a neat spreadsheet to your auditors :)
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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