Software in Medical Devices, by MD101 Consulting - When Web meets SOUP - 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:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearWhen Web meets SOUP - jeromeurn:md5:85b29e5300066352778286de3ea295892021-09-13T11:29:53+02:002021-09-13T10:29:53+02:00jerome<p>Thank you Mitch,</p>
<p>Your article is very interesting. I follow you completly about SOUP management and conclusion : change control, no automatic updates.<br />
This problem of SOUP management becomes very hard with new technologies (web, cloud, mobile...). It was easier when we had only microprocessor !</p>
<p>Don't forget to think about OTSS validation when you start cloud application, it can be so much time to spend. And think about silent update from cloud platform...</p>
<p>thx</p>When Web meets SOUP - Mitchurn:md5:4f8e8ab235ac5086c3386f01700e6bd32021-09-12T20:08:28+02:002021-09-12T19:15:18+02:00MitchThanks Yan for your feedback.<br/>
Qualifying a supplier usually relies on a purchase procedure somewhere else in the QMS, far from software design! The idea is to reuse this procedure and apply specific criteria to software vendors and/or open-source projects.<br/>
Criteria like:<br/>
<li>Is the supplier ISO 9001 or ISO 13485 certified?</li>
<li>Is the supplier ISO 27001 certified?</li>
<li>Does the supplier exist since more than 5 years?</li>
<li>Does the supplier supplies more than 3 software?</li>
<li>What is the turnover of the supplier?</li>
<li>Does the supplier answer our questions?</li>
<li>Does the supplier provide a list of known bugs?</li>
<li>Are the open major bugs acceptable?</li>
<li>Does the supplier provide updates of the software tool?</li>
<li>What is the delay between 2 updates?</li>
<li>Is the open-source project supported by a major player?</li>
<li>Are there frequent contributions to the open-source project?</li>
<li>What is the user-base of the open-source project?</li>
These criteria aim to ensure that the software is stable, reasonably free of bugs and that it won't be made obsolete in the near futureWhen Web meets SOUP - Yanurn:md5:dd7f6563b5b3b01d9e1e565f848bb3c52021-09-07T13:06:23+02:002021-09-12T19:03:39+02:00Yan<p>Thanks for the great article! Do you qualify SOUP suppliers? Some SOUP items like programming language and libraries may have a direct impact to the product, how do you qualify them?</p>