Software

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Dwaaldetectie

Onderstaand artikel is op 11 mei 2016 gepubliceerd in de nieuwsbrief van eGPO. ‘Tijdens het juridisch inloopspreekuur in de Zorginnovatiewinkel op 13 april werd aan mij (Sofie van der Meulen, Axon science based…

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In, on and near body networks EU regulation

I had the pleasure of being invited to speak at the Health IT forum at the MEDICA conference last week on regulation of in, on and near body networks. Most of my…

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Surprise! More on unannounced audits, this time on software

Further to my recent posts on unannounced audits I have been thinking about how unannounced audits could play out in an area that becomes more and more important: standalone software. Software medical devices…

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Updates, patches, add-ons, plugins & the Blue Guide

Here is some follow up on the previous Blue Guide post: the new version of the Blue Guide is the first to address software updates to CE marked products, including software. For the…

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The MHRA's new guidance on standalone software as medical device and DIA Euromeeting update

A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between…

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IMDRF Software as Medical Device definition document completes

In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number…

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CE certification of standalone software and apps seminar – the movie

Rather than streaming our last medical technology seminar on CE Certification of Standalone Software and Apps of 16 October in real time (big hassle and very prone to tech glitches we’ve found), we…

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Healthcare software enforcement alert

If you are active in the medical software field in the Netherlands you may probably be aware already that the the Dutch healthcare Inspectorate IGZ has announced that it will rigorously enforce…

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