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Erik Vollebregt
The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7….
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Erik Vollebregt
This will be a very short post, because everything I could write down on the subject is in the interview I had with Ashley Yeo of Scrip Regulatory Affairs, that kindly consented…
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Erik Vollebregt
Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the…
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Erik Vollebregt
Reader warning: this will be a longer-than-usual post, because I did not have time to write a short one (to cite the many philosophers and writers credited for this quote). The European…
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Erik Vollebregt
With the revision of the EU medical devices directive that entered into force last year stricter requirements on usability engineering have entered into force. The very first essential requirement under that directive…