Software in Medical Devices, by MD101 Consulting - What is software validation? - 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:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearWhat is software validation? - sagaiurn:md5:54909403421ca63f8eac13396f9b9cee2012-11-05T10:42:10+01:002012-11-05T10:42:10+01:00sagai<p>I like the way and the concept of this article.</p>
<p>However in my universe I am having a more holistic view and every activity fall into the scope of the validation, as long as we do that for the purpose of ensuring the fulfilments of the intended use. Having said that, it includes configuration management, risk management, project management, verification, reviews, etc.</p>
<p>But it is only about semantics.</p>