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Erik Vollebregt
With this post I would like to make good on a promise I made some time ago: that I would also do an analysis of the proposed IVD Regulation in more or…
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Erik Vollebregt
While everybody is running around about the MDR and IVD regulations proposals another storm is brewing in the wings: unannounced audits, which I announced earlier. Currently notified bodies “may” do unannounced audits…
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Carine van den Brink
This seminar addressed the new Dutch company law concerning corporate structure and governance. Speakers and their presentations: Ernst Rozelaar, Schut Van Os notarissen New Dutch company law Carine van den Brink, Axon Lawyers…
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Erik Vollebregt
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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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
Well, the 26 February workshop is behind us. The expectations were high, but I think in the end the workshop turned out to be the dud I expected; some people I spoke…
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Erik Vollebregt
I attended the Informa PMS surveillance conference in Berlin on 27 and 28 February, and thought I’d share some of the interesting things I picked up there because to me it was…
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Erik Vollebregt
With the ENVI committee “workshop” on the medical devices regulation and IVD regulation proposals in sight next week, medical devices media have been drumming up momentum by using exciting adjectives like “fireworks” that make…
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Erik Vollebregt
The DIA Euromeeting is quickly becoming a more an more interesting event for the medical devices community, as the DIA has been working on getting a full devices theme in place for…