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Erik Vollebregt
Sweden is a lovely and industrious country that takes engineering very seriously; the small Scandinavian country that we know from its boxy but good cars also builds its own fighter jets (pretty good…
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Erik Vollebregt
In the series of articles on this blog discussing parts of the proposed EU medical devices and IVD regulations I am taking a look now at economic operators, or as Maurizio Suppo…
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Karin Verzijden
This seminar addressed the legal and regulatory developments relevant to bringing novel food products to the market. Speakers and their presentations: Roger van Hoesel, Start Life Future of Food Karin Verzijden, Axon…
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Erik Vollebregt
If you’re active in the medical devices industry in Europe you will no doubt have come across EU data protection regulation. It applies to all personal data (including data concerning health) relating…
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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
Last week the EU Court decided Brain Products / BioSemi, one of the pending borderline cases involving demarcation between medical devices and ‘general stuff’. This case is interesting and important because it…
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Erik Vollebregt
The seminar addresses the changes in the new medical devices regulation compared to current legislation. Speakers and their presentations: Sabine Hoekstra-Van den Bosch, Philips Healthcare Recast of Medical Device Directives Luc Sterkman,…
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Erik Vollebregt
I visited the RAPS Regulatory Convergence conference in Seattle, which provides for a very nice opportunity to catch up with the European medical devices crowd that had gathered in numbers to explain…