Software in Medical Devices, by MD101 Consulting - Tag - Agile - 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:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearAAMI 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>IEC 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>[ping] How to develop medical device software with agile methods? - Part 2 - Anonymous blogurn:md5:6cdb2b350f647e02591285fdcdbf488b2014-10-03T14:19:01+02:002014-10-03T15:12:33+02:00Anonymous blog<p><a href="http://hgomersall.wordpress.com/2014/10/03/from-test-driven-development-and-specifications/">From test driven development and specifications |</a></p> <!-- TB -->
<p>(…) There's an interesting series of blog posts (beginning here) I was reading in which agile methodologies for medical software is discussed. One solution (described as Agile (…)</p>[ping] How to develop medical device software with agile methods? - Part 1 - Anonymous blogurn:md5:f25de66fddb96bb36419dbe738adba0e2014-10-03T14:18:58+02:002014-10-03T15:13:16+02:00Anonymous blog<p><a href="http://hgomersall.wordpress.com/2014/10/03/from-test-driven-development-and-specifications/">From test driven development and specifications |</a></p> <!-- TB -->
<p>(…) There's an interesting series of blog posts (beginning here) I was reading in which agile methodologies for medical software is discussed. One solution (described as Agile (…)</p>How to develop medical device software with agile methods? - Part 1 - Sandraurn:md5:bd443959bcee7f76694b774c8620fcab2013-12-07T00:59:28+01:002013-12-07T00:59:28+01:00Sandra<p>Hi there, I enjoy reading through your article post.<br />
I wanted to write a little comment to support<br />
you.</p>AAMI TIR45 on the use of agile methods becomes new FDA recognized standard - Mitchell Posadaurn:md5:c3d0f2c96ac453070071c8318aecc6ae2013-03-22T17:18:39+01:002013-03-22T17:18:39+01:00Mitchell Posada<p>Thank you for including a post on Agile in Medical Software Development. This is an important topic for anyone doing software development in Healthcare and why we write a lot about it --> <a href="http://bit.ly/YKoRnx" title="http://bit.ly/YKoRnx" rel="ugc nofollow">http://bit.ly/YKoRnx</a> also for more info look for #agile hashtag or visit <a href="http://agilemethodology.org/" title="http://agilemethodology.org/" rel="ugc nofollow">http://agilemethodology.org/</a></p>What is software verification? - Warrenurn:md5:22d45f8060adb61db927701de9b6cac32012-11-12T15:34:11+01:002012-11-12T15:34:11+01:00Warren<p>Thanks Mitch. Lots of good information here.<br />
When discussing verification "activities", we should also include code reviews and code inspections (Fagan analysis, etc). These are powereful defect containment activities, every bit as effective as testing when they are done correctly. And every iteration of a software development cycle, even for bug fixes only, should be driven by a written software V & V plan that calls out the content of the development cycle (the requirements -- next article?) and the V & V activities planned.<br />
Looking forward to your comments on validation.</p>How to develop medical device software with agile methods? - Part 2 - Mitchurn:md5:2bfba7e281695c5271c835b04fd6592a2012-06-11T23:47:51+02:002012-06-11T22:47:51+02:00Mitch<p>Merci Loic.</p>
<p>I appreciate your comment and links.</p>
<p>Continuous certification sounds quite promising, I have to confess I didn't
know it.</p>
<p>I'll see thouroughly what the concept of continuous certification is. Maybe
I could make a post about its application to medical devices.</p>How to develop medical device software with agile methods? - Part 3 - Loïc Fejozurn:md5:f152b472a3a6b4af0bb3e8b3a1459bd62012-06-11T14:35:01+02:002012-06-11T13:35:01+02:00Loïc Fejoz<p>In addition to my previous comment, and after googling for "continuous
certification" embedded or "agile certification", I found (again) those
presentation of interest :</p>
<p><a href="http://www.slideshare.net/AdaCore/challenges-of-agile-qualification" title="http://www.slideshare.net/AdaCore/challenges-of-agile-qualification" rel="ugc nofollow">http://www.slideshare.net/AdaCore/c...</a></p>
<p><a href="http://www.slideshare.net/AdaCore/agile-methods-and-safety-critical-software-peter-gardner" title="http://www.slideshare.net/AdaCore/agile-methods-and-safety-critical-software-peter-gardner" rel="ugc nofollow">
http://www.slideshare.net/AdaCore/a...</a></p>
<p>Have a nice read,<br />
Loïc</p>How to develop medical device software with agile methods? - Part 2 - Loïc Fejozurn:md5:0c49b2a3dd28c33ac5509dd8e98484da2012-06-11T14:26:15+02:002012-06-11T13:26:15+02:00Loïc Fejoz<p>Hi,</p>
<p>Interesting thoughts!<br />
Yet I believe one can go further as it happens in other areas, like aeronautic
or rail transportation.<br />
But to achieve "continuous qualification" or "continuous certification", It
seems mandatory to go through model-based system engineering...</p>
<p>Here is a few links that have resources on this topic.</p>
<p><a href="http://www.embeddedtechmag.com/component/content/article/8212?start=2" title="http://www.embeddedtechmag.com/component/content/article/8212?start=2" rel="ugc nofollow">http://www.embeddedtechmag.com/comp...</a></p>
<p><a href="https://forge.open-do.org/plugins/moinmoin/qmachine/1_Presentation" title="https://forge.open-do.org/plugins/moinmoin/qmachine/1_Presentation" rel="ugc nofollow">https://forge.open-do.org/plugins/m...</a></p>
<p><a href="http://www.open-do.org/" title="http://www.open-do.org/" rel="ugc nofollow">http://www.open-do.org/</a></p>
<p>--<br />
Regards,</p>How to develop medical device software with agile methods? - Part 1 - Tony Johnsonurn:md5:916540174f1bb8dcd38d5987d20bbf7d2012-05-25T14:07:45+02:002012-05-25T13:07:45+02:00Tony Johnson<p>Is it possible to obtain copies of the powerpoint slides or visio diagrams
for this article? I would like to re-use the digrams in a presentation.</p>How to develop medical device software with agile methods? - Part 1 - Tony Johnsonurn:md5:23e52c9f6915eac9c0dcccd62babf68d2012-05-25T14:07:37+02:002012-05-25T13:07:37+02:00Tony Johnson<p>Is it possible to obtain copies of the powerpoint slides or visio diagrams
for this article? I would like to re-use the digrams in a presentation.</p>