Software in Medical Devices, by MD101 Consulting - Tag - PACS - 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:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearNew Device Classification Guidance published by GHTF: consequences for medical imaging software - Mitchurn:md5:60c3b801e908b6b3d010272750a8d5612013-06-10T22:13:12+02:002013-06-10T21:13:12+02:00Mitch<p>Hi Charles,</p>
<p>No country is impacted by this guidance. It is an international recommendation that countries can use to create their own rules.</p>New Device Classification Guidance published by GHTF: consequences for medical imaging software - Charlesurn:md5:c514248cef9ea690d5af9cc8ecec9b252013-04-19T15:08:48+02:002013-04-19T14:08:48+02:00Charles<p>Very nice; just an update for the guidance URL, it's now <a href="http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf" title="http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf" rel="ugc nofollow">http://www.imdrf.org/docs/ghtf/fina...</a></p>
<p>Which legislation is likely to later follow this guidance?</p>
<p>Cheers!</p>New Device Classification Guidance published by GHTF: consequences for medical imaging software - Charlesurn:md5:2dfb1235299bf57a878dcade6afb09112013-04-19T15:08:24+02:002013-04-19T14:08:24+02:00Charles<p>Very nice; just an update for the guidance URL, it's now <a href="http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf" title="http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf" rel="ugc nofollow">http://www.imdrf.org/docs/ghtf/fina...</a></p>
<p>Which legislation is likely to later follow this guidance?</p>
<p>Cheers!</p>How to classify and CE mark software - Mitchurn:md5:d4d8fc396a6bed4f074197a72573b42a2012-10-27T18:43:19+02:002012-10-27T17:43:19+02:00Mitch<p><br _moz_editor_blogus_node="TRUE" _moz_dirty="" /></p>
Thank Tomasz,
<br />Typo fixed.How to classify and CE mark software - Tomasz Pukurn:md5:19496d252fff34099e3df6fea29cdb392012-10-26T12:27:02+02:002012-10-26T11:27:02+02:00Tomasz Puk<p>Hi Mitch,</p>
<p>Great article, thank you for explaining that issue.</p>
<p>BTW IEC60610-1 should be rather IEC60601-1.</p>
<p>Regards,<br />
Tomek</p>