Software Test Documentation For IEC 62304 Compliance (Medical Device Software)
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/formwork
Видео Software Test Documentation For IEC 62304 Compliance (Medical Device Software) канала OpenRegulatory
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/formwork
Видео Software Test Documentation For IEC 62304 Compliance (Medical Device Software) канала OpenRegulatory
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10 марта 2025 г. 15:45:01
00:24:36
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