QUOTED. Dec. 7, 2017. Erik Vollebregt.
Executive SummaryCheck out what attorney Erik Vollebregt had to say about the threat of device companies losing their current notified body as the EU transitions to its new Medical Device and IVD Regulations.
"As a company, you have to create a situation where if you are dumped, the quality of your dossiers is such that you have the best chances to be recertified quickly by another notified body – which means that you have to make sure everything is state-of-the-art." – Erik Vollebregt, partner, Axon Lawyers
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