Software in Medical Devices, by MD101 Consulting - 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 820.2024-03-18T07:25:39+01:00Cyrille Michaudurn:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearIEC 81001-5-1 Right Here Right Now - Mitchurn:md5:cfd95641de5fc681162e09d6dc86c5872024-02-28T17:30:06+01:002024-02-28T17:30:06+01:00Mitch<p>HI Peter,<br />
Thanks for your feedback.<br />
Yes, it was supposed to be harmonized by May 2024. But the MDCG WG on standards held a meeting the 19 January 2024. This report states that it is being postponed to 2028. There is no official information. But you can find it on lnkn.</p>IEC 81001-5-1 Right Here Right Now - Peter Olssonurn:md5:72d333446a9a6d0339d5ef7a968874b22024-02-26T13:56:48+01:002024-02-26T13:56:48+01:00Peter Olsson<p>Hi,</p>
<p>Interesting article! I have a consideration about the harmonzation of 81001-5-1 during 2028. I thought that 81001-5-1 was supposed to be harminized May 27th this year (2024)?</p>Template: Software Design Description - baoualiurn:md5:3a61ea821d34cbdf5227fabc28f751282023-04-27T07:58:46+02:002023-05-03T15:39:45+02:00baouali<p>thank you in advance</p>Manual on Borderline Classification Version 2 - December 2022 - Mitchurn:md5:e1bff38840333a8ce2fe350bfcc7dd172022-12-19T21:17:55+01:002022-12-19T21:17:55+01:00Mitch<p>I don’t think it is contradictory. Their argument is that conception is neither diagnosis nor treatment. Thus not doomed by the first paragraph of rule 11.</p>Manual on Borderline Classification Version 2 - December 2022 - MikeZurn:md5:e45c0e3f0e12b1cd2fc26d88d81d370a2022-12-19T17:42:40+01:002022-12-19T17:42:40+01:00MikeZ<p>Definitely an overkill. More clueless people writing regulations.<br />
Also, isn't this in conflict with the example from MDCG 2021-24 for "MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm" on page 44?</p>Software 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>MDCG 2020-3: Substantial change or not Substantial change? - Mitchurn:md5:04c73420b9b3d4c4f755d4bb7760c3da2022-10-07T14:27:08+02:002022-10-07T13:27:08+02:00MitchHi Tomtom, you're right!MDCG 2020-3: Substantial change or not Substantial change? - TomTomurn:md5:508ddf06b1c8fd694b9762f853f2b5872022-10-06T11:15:08+02:002022-10-06T10:15:08+02:00TomTom<p>Hello !<br />
Thank you for the article !<br />
However, shouldn't we talk in this article about "significant changes" and not "substantial changes" ? Those are two different types of changes and the guide MDCG 2020-03 talks about significant changes.<br />
thanks :)</p>Is my software in class A, B or C? - Mitchurn:md5:8f49068be58b8057c2e9e4ffc707b0ae2022-09-21T18:34:50+02:002022-09-21T17:34:50+02:00MitchHi, the medical image database only for storage is not regulated as medical device. Regards.Is my software in class A, B or C? - Shubhangi Chouhanurn:md5:53e3ba58e251a621563da3e7ae04edea2022-09-19T15:24:37+02:002022-09-19T14:24:37+02:00Shubhangi Chouhan<p>My SW system has three items:</p>
<p>1) User Interface: used for user login, (Non medical)<br />
2) Data Storage: used for secure storage and retrieval of patients wound image Class ??<br />
3) Image analyzer: used to sizing and segmentation of wound to suggest treatment to nurse (classIIa)</p>
<p>My question is about the data storage platform Item, is that consider as MD, if this only for storage purpose?</p>
<p>Thank you</p>The MDR is born bad - Francisco Falociurn:md5:0023eb9b20ec4f42cea54254e0186a882022-06-21T19:33:18+02:002022-06-21T18:33:18+02:00Francisco Faloci<p>I totally agree with your text, and unfortunately, there was no adequate planning of activities by the MDCG.<br />
In another example, PSURs are still a great mystery for several manufacturers, and there is still no template to demonstrate the minimum necessary information.</p>
<p>Kindly regards</p>
<p>Francisco</p>Class A, B and C. When to do detailed design of software medical devices? - Mitchurn:md5:65425c292ee7ab5b147a01e417da2ed02022-05-20T22:32:53+02:002022-05-20T21:32:53+02:00MitchThanks for your question!
I agree with you about traceability.
You can do like what you wrote, because IEC 62304 is a recognized standard. Please also note that the word "likely" appears in the title of the table for major and moderate levels of concern.Class A, B and C. When to do detailed design of software medical devices? - TomTomurn:md5:42d603502358824819120cb72caeb0332022-05-17T16:45:00+02:002022-05-17T15:45:00+02:00TomTom<p>Hi !<br />
Thank you for content ! I highly appreciate it :)<br />
I have a question concerning the 62304 classification (A,B and C) and the Software Detailed Design(SDS) of clause 5.4 of IEC 62304, so this would be for EUROPE.<br />
For example, If I have 5 Software items that are class A and 1 Software item that is a class B, clause 5.4.1 specifies that the SDS is only necessary for class B components.</p>
<p>Therefore, in my SDS document we could have only the detailed specification of the Class B component, so therefore in terms of traceability we would have :<br />
- Class A component : Requirement (SRS doc) -> test case (V&V)<br />
- Class B component : Requirement (SRS doc) -> Specification (SDS doc) -> test case (V&V).<br />
Is that correct?</p>
<p>Finally, in the US, the classification of the software is determined by the level of concern (which is similar to the 62304 but not exactly the same, which is the case for our device.)<br />
The level of concern seems to give the software classification of the WHOLE software, per this guidance. However, is it possible to isolate each software component and evaluate their own class, like the IEC 62304? This would avoid us to document specifications for low class (MINOR - class A) software Items and we would have :<br />
- Class "MINOR" component : Requirement (SRS doc) -> test case (V&V)<br />
- Class "MODERATE" component : Requirement (SRS doc) -> Specification (SDS doc) -> test case (V&V).<br />
Plus, the IEC 62304 is a Recognised consensus standard so this can be justified ?</p>
<p>Any feedback would be so helpful !!!<br />
Thank you very much :)</p>Medical Device lifetime and SaMD - D Graingerurn:md5:bf1dce4e85e2e6be22c6289b120dff0d2022-02-25T17:20:48+01:002022-02-25T17:20:48+01:00D Grainger<p>Don't forget, you also need to have documentation "available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market"</p>Probability of occurence of a software failure - Aliurn:md5:7e8227ed3f3475cabe2387a313d05a9f2022-02-16T14:50:24+01:002022-02-16T14:50:24+01:00Ali<p>Thank you for this informative post. But I think, in some places you calculated the total probability by multiplication (if the events be dependent, you have to calculate the total probability by conditional probability formulas).</p>Ten years - alexandraurn:md5:78e98550d2d4cf2ce1e88e6ab2179b672021-11-08T11:54:20+01:002021-11-10T09:55:58+01:00alexandra<p>Happy birthday!<br />
Toujours un plaisir de te lire!</p>AAMI TIR45 on the use of agile methods becomes new FDA recognized standard - Mitchurn:md5:878ea60c546034b19d11dc7fdbb8ff912021-10-06T20:08:48+02:002021-10-06T19:08:48+02:00Mitch<p>Sorry I didn’t have time to review it.</p>AAMI TIR45 on the use of agile methods becomes new FDA recognized standard - Sangeethaurn:md5:7073ec461c957ba259a8753f6bab87e72021-10-05T09:14:03+02:002021-10-05T08:14:03+02:00Sangeetha<p>What is the change between 2012 and 2018 version of TIR 45</p>Brexit: Regulating medical devices from 1 January 2021 in the UK - David Graingerurn:md5:cfd4f0ab4a4efd73c274be88e28cd9a42021-09-16T14:36:49+02:002021-09-16T13:36:49+02:00David Grainger<p>Consultation on the future regulation of medical devices in the United Kingdom:<br />
<a href="https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom" title="https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom" rel="ugc nofollow">https://www.gov.uk/government/consu...</a></p>