Software in Medical Devices, by MD101 Consulting - Three templates - CommentsBlog about software medical devices and their regulatory compliance. Main subjects are software validation, IEC 62304, ISO 13485, ISO 14971, CE mark 93/42 directive and 21 CFR part 820.2024-03-27T15:32:28+01:00Cyrille Michaudurn:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearThree templates - Mitchurn:md5:e94b26c8eef5e9952506c8b6b0c3cb802012-09-17T09:55:10+02:002012-09-17T08:55:10+02:00Mitch<p>Hi Joe,</p>
<p>IMHO, the documentation needed for validation should more than that. You can make a reference to</p>
<p>-a verification tests report</p>
<p>-a validation tests report: same template as the verification, with the characteristics you mentionned</p>
<p>-and a validation review report , where company managers / QA-RA managers / end-users / doctors should validate the device.</p>
<p> It implies that a validation review shall be planned at the end of all tests (including clinical tests, if any) to ensure that the device is validated.</p>
<p>If your software is embedded in a hardware medical device, then the validation is for the whole thing software + hardware. So the validation can happen only after system (hard+soft) tests.</p>
<p>If our software is standalone, then the validation is for the software itself.</p>Three templates - Joseph Coptyurn:md5:d5d899f8f8120e59f6ae4eefddddedbc2012-09-13T06:27:56+02:002012-09-13T05:27:56+02:00Joseph Copty<p>Hi Mitch,<br />
Thanks for your post.<br />
What are your thoughts on what a Validation Report should look like?<br />
I can't think of any differences to the Verification Report template you have posted, except of course it contains the validation activities instead of verification ones. ie system and user acceptance tests.<br />
I also think it is a good idea to refer to the Verification report in the validation report.</p>