Software in Medical Devices, by MD101 Consulting - Class A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices? - 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:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearClass A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices? - Mitchurn:md5:731139c74309320a3eb0df0e780646422018-02-17T16:56:02+01:002018-02-17T16:56:02+01:00Mitch<p>Hi Murielle,</p>
<p>The hardware risk control is required to downgrade form C to B or B to A without isolation/segregation. But according to 4.3.d, the segregation can be software/logical or hardware/physical. But you shall bring strong rationale for a logical segregation. Usually, it is better admitted to have logical separation between classes A and B, and physical between C and B.</p>
<p>Bye.</p>Class A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices? - Murielleurn:md5:540bfc56fcd2f03177a8bde98a5469162018-01-26T15:06:19+01:002018-02-17T16:49:05+01:00Murielle<p>Thank you for this post<br />
I have a question<br />
You write that the "The isolation may also be physical". So I assume that the interface may be done by software (for exemple with mutex, queue if using an OS).<br />
But when I read EN62304:2006 4.3.a, there is only hardware risk control measure which can reduce the software safety classification.<br />
So the interface can be only physical with consequence to run software items on separate hardware or I'm wrong in comprehension?<br />
Thanks for your response</p>Class A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices? - Mitchurn:md5:ebe4d8e4190f037be2f7e08ff14a4cf62017-12-08T16:00:41+01:002017-12-08T16:00:41+01:00Mitch<p>Thanks for your feedback.</p>
<p>Yes, it's possible to downgrade from class C to class A with two mitigation actions.</p>Class A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices? - Mathieu Febvayurn:md5:09a67e0aebfc23cfe2a5d1cded2130112017-12-05T17:16:57+01:002017-12-05T17:16:57+01:00Mathieu Febvay<p>Thank you for this trick !</p>
<p>However, when you isolate your software like you did, is the interface manager mandatory class B ?</p>
<p>Is it possible to switch from class C item to class A with risk mitigation measures (CRC and another hardware/software checks the class C item) ? (EN62304:2006 4.3.a explains that is possible to switch from class C to class B AND from class B to class A)</p>
<p>Again, thank you for all your valuable informations.</p>
<p>Mathieu.</p>