apps

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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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More on mHealth and e-labeling

Further to my recent post about e-labeling and my appeal to take more account of the specific mHealth market needs I had a discussion with another devices expert who suggested that the majority of medical…

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EU privacy requirements for (healthcare) apps – the Article 29 Working Party weighs in

The European Article 29 Working Party has just released its opinion 02-2013 on apps on smart devices. This detailed opinion provides very useful and detailed guidance for companies developing and distributing healthcare…

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Happy New Year – with all those developments

The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year…

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The new Commission eHealth Action Plan, and some thoughts on what it will mean for devices

Last week the Commission launched its new eHealth Plan (EHAP). It was announced under the header “Putting patients in the driving seat: A digital future for healthcare”. A nice rundown of the…

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The new EU MEDDEV on stand-alone software as medical device

Some time ago I already gave you a look under the hood of it and now it is here, the new MEDDEV on stand alone software: an interesting document that provides a…

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CE marking of apps: It Can Be Done and Here Is How

If there is one thing that I have learnt by now working with medical apps and medical device law is that physicians have little idea about rules for apps with medical functionality,…

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Regulating Medical Software and nothing new on the Recast

Today I attended the COCIR workshop Regulating Medical Software in Brussels, a very interesting event that brought a lot of new information to my attention and I had the opportunity to speak…

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