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Karin Verzijden
In the beginning of the new calendar year, people tend to stick to new year’s resolutions, such as eating healthier. In supermarkets and other stores choosing healthy/ sustainable products is made easy…
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Erik Vollebregt
The year is off to a good start, and so should your company be with its MDR and/or IVDR transition plan. Come again? You haven’t started looking at this yet because the…
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Karin Verzijden
Recently the European Court of Justice (‘CJEU’) clarified the definition of personal data under the Data protection Directive. In the Breyer case[1] the CJEU ruled on whether or not a dynamic IP…
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Karin Verzijden
The European Union Agency for Network and Information Security (‘ENISA’) published an updated version of its National Cyber Security Strategy Good Practice Guide (‘the Guide’) on 14 November 2016, which includes a…
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Erik Vollebregt
Change is on its way – medical devices law will not be the same again as of next year. Panic soccer The authorities are not your friend anymore. Notified bodies are engaging…
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Erik Vollebregt
I’ve often warned medical devices companies that they need to start looking at privacy by design obligations under the General Data Protection Regulation, the GDPR. Engineers at a company where I gave…
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Erik Vollebregt
With the MDR and IVDR adoption in sight (currently scheduled for Q1 2017) I see a number of developments in the market, all converging on the higher standards that will be imposed under these…