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Erik Vollebregt
I attended an interesting seminar today about software as medical device organised by NEN, the Dutch standardisation institute. Speakers at the seminar highlighted the different views on this subject from the perspective…
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Erik Vollebregt
On 28 April 2010 the European Commission published the SCENHIR’s opinion on reprocessing of medical devices, which was adopted by the SCENHIR on 15 April 2010. This opinion was commissioned pursuant to…
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Erik Vollebregt
People have been asking me for copies of my presentation “From Bench to Bedside” about legal and regulatory aspects of bringing a newly developed in vitro diagnostic device to the market that I…
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Erik Vollebregt
In a judgment of 20 September 2010 the The Hague District Court ruled that it was OK for AED that are CE marked to not be accompanied by paper instructions for use…