Software in Medical Devices, by MD101 Consulting - Software release vs design transfer - 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:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearSoftware release vs design transfer - Mitchurn:md5:896ed021401e600aa25233dfa80457042022-12-13T14:24:23+01:002022-12-13T14:24:51+01:00Mitch<p>Hi Matt<br />
IEC 62304, IEC 82304 all are applicable. I totally agree with you.<br />
As you say, delivery is different. And this is exactly where 4.1.6 or, more precisely 7.5.6 is applicable. When the manufacturer puts the device into production on servers under their responsiblities, they shall verify that the installation went well. Thus something like an installation qualification is required.<br />
More, if manufacturer's personnel perform some service with the SaMD (e.g. medical images segmentation / analysis) then they shall be trained to the device, and some performance qualification shall be performed.<br />
Regards.</p>Software release vs design transfer - mattVurn:md5:df29c3230bbdef7d90dc4f7047b49ecd2022-12-05T15:12:44+01:002022-12-05T15:12:44+01:00mattV<p>Hi Mitch<br />
Thankyou for your articles. I do have two questions.<br />
1) 4.1.6 of ISO 13485 :<br />
Did not understand why 4.1.6 is required for SaMD in SaaS context.<br />
4.1.6 is about the validation of tools used in the development (non product software ?)</p>
<p>2) What would be different in the agile software development cycle for SaaS. Is there any difference at all? IEC 62304, IEC 82304 all are applicable i guess. Only the delivery/distribution is different ?</p>