Software in Medical Devices, by MD101 Consulting - Tag - IEC 62366 - 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:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearIEC 62366-1 and Usability engineering for software - Hobberurn:md5:749d11257d378959cda79a8ff4aa360b2019-12-17T13:07:26+01:002019-12-17T13:07:26+01:00Hobber<p>That was really useful, thx a lot. You explained the human, knowhow side of doing it, that others don't.</p>Software Medical Devices. How to obtain market homologation? - Mitchurn:md5:510f915036e13c257a4b3208d713931a2018-03-26T16:05:57+02:002018-03-26T15:05:57+02:00Mitch<p>Thanks Michail :-)</p>Software Medical Devices. How to obtain market homologation? - Michailurn:md5:5c4c0b9d98e641e6f8260824f2cbcc982018-03-23T14:16:42+01:002018-03-26T15:05:33+02:00Michail<p>I think this is one of the best articles od the blog. I suggest that you pin it somehow, so that it can be a short but really helpful guide to medical software development.</p>ISO and IEC standards for software in medical devices in a nutshell - Syedurn:md5:7baaf9d448fdf19cb5fbb669a945cbda2017-09-13T21:15:50+02:002017-09-13T20:15:50+02:00Syed<p>Thanks very simplified</p>IEC 62366-1 becomes recognized by the FDA - Mitchurn:md5:600f7e00b0b40ff84cad940bb058b7bd2017-08-30T18:05:22+02:002017-08-30T17:05:22+02:00Mitch<p>I wish I had time to do so.</p>IEC 62366-1 becomes recognized by the FDA - jokourn:md5:54a33098b6b41d62512d1fa109dd560e2017-08-29T13:48:57+02:002017-08-30T17:04:27+02:00joko<p>Is the update of the template still on the todo list? I am looking forward to the updated version.</p>IEC 82304-1 - Overview of requirements - Mitchurn:md5:7b4e19c3fd7432a2f7525fea338b60392016-12-06T20:49:35+01:002016-12-06T20:53:38+01:00Mitch<p>Hi Bart,</p>
<p>No, I don't think IEC 82304-1 makes a distinction here.</p>
<p>Most of mobile apps communicate with a backend server. The backend may or may not be a medical device, depending on the functionalities on this server.</p>
<ul>
<li>If it only stores data as is, then that's not a medical device, per MEDDEV 2.1/6,</li>
<li>If it computes new data from raw data, and this new data are used for diagnosis or treatment (or as an help to diagnosis or treatment), then the backend may be deemed a medical device.</li>
</ul>
<p>Trying to understand your case, the backend is not a medical device and it was outsourced to a developer. I believe that if you want to apply the end of clause 5 to you outsourced development, then you're tweaking the clause 5. Clause 5 is applicable if the backend is for example a cloud server with off-the-shelf services like Amazon S3. </p>
<p>With your words, I don't think that IEC 82034-1 makes the distinction.</p>
<p>Bye</p>IEC 82304-1 - Overview of requirements - Bartvpurn:md5:a5e09c1e7cf3404657832e10cecf90292016-11-28T14:46:45+01:002016-11-28T14:46:45+01:00Bartvp<p>Hi Mitch,</p>
<p>Thanks for the wonderful articles.<br />
IEC 82304-1 section 5 talks about 'subsystems of non-healthcare origin' that come with reduced requirements on for example risk management, which you say mimics the SOUP concept of IEC 62304.<br />
Would these subsystems of non-healthcare origin encompass outsourced 'health software' development (not classified as a medical product)? Talking about mobile apps for example, there's often a more complex algorithm that can be confined to a small controllable (sub-)system (perhaps not even running on the phone), with much of the interfacing, user interaction, data transmission etc. not classified as a medical device, and outsourced to a developer.<br />
I know that you would consider such outsourced development as 'internally produced' software according to your VMP since it was developed based on the manufacturer's requirements, and would therefore also subject it to DQ. But do you think that IEC 82304 makes that distinction here?</p>
<p>Regards,<br />
Bart</p>IEC 62366-1 becomes recognized by the FDA - Mitchurn:md5:6e0ab3044ad4bd895b5288dab4f60ef42016-06-23T21:06:13+02:002016-06-23T20:06:28+02:00Mitch<p>Thanks Luis for your feedback.</p>
<p>No, the actual template doesn't match the new requirements of IEC 62366-1 on formative and summative evaluation. I add to my todo list the action to update the template.</p>IEC 62366-1 becomes recognized by the FDA - Luis Gurn:md5:eb47d86e7a883407131392691898ac6c2016-06-17T10:25:27+02:002016-06-23T20:04:05+02:00Luis G<p>You have posted a template for the Usability Specification Document, but since the norm has changed, does the document need to be updated or it can be used the same template?</p>
<p>You blog has been a lot of help</p>IEC/FDIS 62366-1 released in November 2014 - Claudia Bachurn:md5:d4c5af04e7ac9d170ba45b22bbefd4bc2015-03-05T17:53:08+01:002015-03-06T14:40:56+01:00Claudia Bach<p>FYI: The new IEC 62366-1 2015 Edition 1.0 has just been released. It replaces IEC 62366. The part 2 (IEC 62366-2) is still in process and not yet available.<br />
If you would like to read more about the new release, you are welcome to take a look at my review of the document at StandardsForum.com. </p>
<p>Thanks!<br />
Claudia<br />
Claudia Bach<br />
Document Center Inc.</p>ISO and IEC standards for software in medical devices in a nutshell - Jayaurn:md5:e4dd8bba5c46f543343d3e5b6339972f2013-04-04T15:32:51+02:002013-04-04T14:32:51+02:00Jaya<p>Excellent work Cyrille (Mitch).<br />
Thanks and Keep it up.Its very much useful for them who wondering around all these standards.</p>
<p>JN</p>ISO and IEC standards for software in medical devices in a nutshell - Subramanya HRurn:md5:d83528749bb4128b760f4afddd40dd6b2013-02-13T06:32:41+01:002013-02-13T06:32:41+01:00Subramanya HR<p>It is very useful for software engineers who working in medical devices field.<br />
From this software engineers come to know what is use of documentation like specific requirements, design doc etc etc.<br />
Instead of blindly doing the documentation first we should know the reason behind this</p>ISO and IEC standards for software in medical devices in a nutshell - Nicolas S.urn:md5:775572ec8d6c798967003a0842949e3b2012-10-29T17:46:06+01:002012-10-29T17:46:06+01:00Nicolas S.<p>Good introduction to the different standards !<br />
Especially when you're not familiar with lots of medical validation competences.</p>
<p>Keep it that way Mitch,<br />
Thanks.</p>
<p>Nicolas.</p>ISO and IEC standards for software in medical devices in a nutshell - Joseph Coptyurn:md5:61ae07eb930cffd83e851ebe999f087d2012-08-08T08:41:33+02:002012-08-08T11:28:33+02:00Joseph Copty<p>Where is the like button?<br />
Thanks Mitch for this post. I wish I read this a few weeks ago :)<br />
As a software engineer some quality management stuff can be tricky.<br />
Joe</p>