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Erik Vollebregt
Well, the long awaited DRB (Dagmar Roth-Behrendt) report is here. I read through it as quickly as I could, answered a bunch of press questions and can now give you my preliminary…
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Erik Vollebregt
After the GHTF had been decommissioned – much to the disappointment of many – the IMDRF had big shoes to fill and everybody is watching if they manage. The outcome statement of…
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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…