When Gert Bos and I wrote BSI’s white paper on the impending EU medical devices regulation and the IVD regulation, the white paper was received very well but we also received requests to write something more detailed and practical.
Here it is
So we did just that. And here it is – the next BSI white paper on the MDR, written from the perspective of a medical devices manufacturer that is faced with the MDR on the horizon and has to figure out what to do.
Chapter by chapter
We’ve taken the M [...] « Read the rest of this article on