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Erik Vollebregt
Many companies developing medical software, especially the smaller app developers, have difficulties applying the EN62304 standard. For that reason a number of experts under the auspices of Team NB started work on…
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Erik Vollebregt
I had the privilege to preside a session about eHealth and mHealth at the DIA Euromeeting in Amsterdam last week, joined by Mr Tapani Piha, Head of Unit for eHealth, Health Technology…
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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
In a previous post I have analysed the consequences of the European Court of Justice’s Ker-Optika judgment for e-commerce in physical medical devices. This post extrapolates the reasoning of the European Court…