Software in Medical Devices, by MD101 Consulting - Tag - GDPR - 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 820.2024-03-29T12:42:03+01:00Cyrille Michaudurn:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearUpdate of SRS and SAD templates for GDPR - Mitchurn:md5:0788db886ed7c9f4eb2235a4171b99aa2018-10-21T14:51:51+02:002018-10-21T13:52:49+02:00Mitch<p>Hi Kasia<br />
This is just an example.<br />
Bye</p>Update of SRS and SAD templates for GDPR - Kasiaurn:md5:6d08c3a027e5b47f33c120f344845de92018-10-17T12:58:29+02:002018-10-17T11:58:29+02:00Kasia<p>Hi</p>
<p>I went through your templates adn I can see that in the SRS and also test related documents you use verification method I, A, D, T.<br />
I haven't met this kind of division before and I am interested if this is a mandatory procedure for medical software or only an example how to do verification process?</p>
<p>Thank you</p>
<p>Kasia</p>