The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.
Friday 22 July 2016
Is my software in class I, IIa, IIb or III - 2016 Revolution
By Mitch on Friday 22 July 2016, 13:28 - Regulations