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01. Home | cm-dm.com Reviews
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Conseil logiciel dispositifs médicaux, marquage CE et FDA 510(k), IEC 62304
Software in Medical Devices, by MD101 Consulting
Software in Medical Devices, by MD101 Consulting. Software in Medical Devices, by MD101 Consulting. Software in Medical Devices, by MD101 Consulting. Friday 19 January 2018. FDA Guidance on Medical Device Accessories updated. On Friday 19 January 2018, 14:15 - Regulations. Here is a quick follow-up of the new version of the FDA Guidance titled. Medical Device Accessories Describing Accessories and Classification Pathways. Friday 12 January 2018. Consequences of the 21st Century Cures Act - State of Play.
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CONSEIL EN DISPOSITIFS MEDICAUX LOGICIELS. SOFTWARE MEDICAL DEVICES CONSULTANT. Conseil en homologation de dispositifs me dicaux inte grant du logiciel. Accompagnement à la validation logicielle et à la re daction des dossiers techniques pour l’obtention des homologations. Conseil a la mise en place des processus du cycle de vie des logiciels. Normes Européennes et internationales :. IEC 62304 : 2006 :. Cycle de vie des logiciels,. IEC 60601-1 : 2005:. IEC/TR 80002 1 :. IEC 62366 : 2008 :. Durée : un jour.
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CONSEIL EN DISPOSITIFS MEDICAUX LOGICIELS. SOFTWARE MEDICAL DEVICES CONSULTANT. Conseil en développement, maintenance et homologation des dispositifs médicaux logiciels. We provide software development, maintenance and homologation consultancy to medical device software. Vous êtes responsable Qualité / Réglementaire. Nos consultants ont une large expérience des normes générales ISO 13485 et ISO 14971, des normes relatives au logiciel: IEC 60601-1, IEC 62304 et IEC 62366 et de la validation logicielle.
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Tag - risk management - Software in Medical Devices
http://blog.cm-dm.com/tag/risk%20management
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. Tag - risk management. Friday 5 February 2016. New FDA draft guidance on interoperable medical devices. On Friday 5 February 2016, 13:45 - Regulations. The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. Was published late January 2016. Friday 29 January 2016. FDA draft guidance on Postmarket Management of Cybersecurity in Medical Devices. On Frida...
Happy new year 2015 - Software in Medical Devices
http://blog.cm-dm.com/post/2015/01/09/Happy-new-year-2015
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. 171; NBOG’s Best Practice Guide 2014-3: all you wanted. IEC/FDIS 62366-1 released in November 2014. Happy new year 2015. On Friday 9 January 2015, 14:00 - Misc. Happy New Year 2015! Name or nickname :. Comments can be formatted using a simple wiki syntax. This post's comments feed. Go to my website. View my Google profile. View my Linkedin profile. Creative Commons License (CC-BY-ND). Qualitiso.com (in French).
Tag - Guidance - Software in Medical Devices
http://blog.cm-dm.com/tag/Guidance
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. Friday 19 August 2016. Three new FDA guidances. On Friday 19 August 2016, 13:48 - Regulations. The FDA released three new FDA guidances in July 2016:. Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,. The final guidance on General Wellness: Policy for Low Risk Devices. Wednesday 10 August 2016. MEDDEV 2.1/6 2016. On Wednesday 10 August 2016, 10:09 - Regulations. FDA draft guid...
Tag - FDA - Software in Medical Devices
http://blog.cm-dm.com/tag/FDA
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. Friday 19 August 2016. Three new FDA guidances. On Friday 19 August 2016, 13:48 - Regulations. The FDA released three new FDA guidances in July 2016:. Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,. The final guidance on General Wellness: Policy for Low Risk Devices. Friday 5 February 2016. New FDA draft guidance on interoperable medical devices. Friday 29 January 2016.
Updates to good old IEC 62304 - Software in Medical Devices
http://blog.cm-dm.com/post/2015/04/24/Updates-to-good-old-IEC-62304
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. 171; When the FDA releases guidances in burst mode. IMDRF document: Software as a Medical Device. Updates to good old IEC 62304. On Friday 24 April 2015, 15:48 - Standards. Georg Heidenreich, one of the author of the Frequently Asked Questions on IEC 62304 published on the Team NB website. Posted two weeks ago an article about the upcoming updates in the first amendment of IEC 62304. Name or nickname :. Go to my website.
Tag - CE Mark - Software in Medical Devices
http://blog.cm-dm.com/tag/CE%20Mark
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. Tag - CE Mark. Wednesday 10 August 2016. MEDDEV 2.1/6 2016. On Wednesday 10 August 2016, 10:09 - Regulations. A new version of the MEDDEV 2.1/6 was published in July 2016. The first version of 2012. Add to that a few typos, and you have the new version of the MEDDEV:. Lossless compression" disappeared from the decision tree (was it intentional? But is still present in the explanations of decision step 3,. The British S...
When the FDA releases guidances in burst mode - Software in Medical Devices
http://blog.cm-dm.com/post/2015/03/20/When-the-FDA-releases-guidances-in-burst-mode
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. 171; ISO 13485 201X DIS2. Updates to good old IEC 62304. When the FDA releases guidances in burst mode. On Friday 20 March 2015, 17:03 - Regulations. If you watch from time to time the new guidances released by the FDA, you probably noticed that two guidances about software were released in january and february 2015. We have the :. Guidance released in February,. General Wellness: Policy for Low Risk Devices. This prod...
Tag - IEC 62366 - Software in Medical Devices
http://blog.cm-dm.com/tag/IEC%2062366
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. Tag - IEC 62366. Friday 11 March 2016. IEC 82304-1 - Overview of requirements. On Friday 11 March 2016, 14:53 - Standards. We had in a previous article. An overview of IEC 82304-1. Health software - Part 1: General requirements for product safety. Its scope and its relationships with other standards like IEC 62304. Wednesday 23 September 2015. IEC 62366-1 becomes recognized by the FDA. Friday 9 January 2015. Let's see ...
IEC/FDIS 62366-1 released in November 2014 - part 2 - Software in Medical Devices
http://blog.cm-dm.com/post/2015/01/30/IEC/FDIS-62366-1-released-in-November-2014-part-2
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. 171; IEC/FDIS 62366-1 released in November 2014. ISO 13485 201X DIS2. IEC/FDIS 62366-1 released in November 2014 - part 2. On Friday 30 January 2015, 16:44 - Standards. To continue with the last article about FDIS IEC 62366-1 standard. Let's see now the consequences of this standard on software design. Advanced mockups can be used to elaborate complex workflows or use-cases, to capture the user requirements. The sectio...
Tag - IEC 62304 - Software in Medical Devices
http://blog.cm-dm.com/tag/IEC%2062304
Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. Tag - IEC 62304. Friday 22 July 2016. Is my software in class I, IIa, IIb or III - 2016 Revolution. On Friday 22 July 2016, 13:28 - Regulations. The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015. Friday 8 April 2016.
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CONSEIL EN DISPOSITIFS MEDICAUX LOGICIELS. SOFTWARE MEDICAL DEVICES CONSULTANT. Conseil en développement, maintenance et homologation des dispositifs médicaux logiciels. We provide software development, maintenance and homologation consultancy to medical device software. Vous êtes responsable Qualité / Réglementaire. Nos consultants ont une large expérience des normes générales ISO 13485 et ISO 14971, des normes relatives au logiciel: IEC 60601-1, IEC 62304 et IEC 62366 et de la validation logicielle.
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Auto sostitutiva a noleggio. Rigenerazione Cerchi in Lega. Riparazioni auto da competizione. Esempi di restauri e riparazioni. Rigenerazione e riparazione interni auto in pelle. Riparazione e verniciatura rimorchio camion. Rigenerazione cerchi in lega. CM-DM LA NOSTRA AZIENDA. È da parecchi anni inserita nella realtà economica dell alto vicentino con due settori di lavorazione distinti:. La nostra attività di carrozzeria nasce nel marzo del 1977, nella comunità di Torrebelvicino in una piccola sede.
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