Happy IVDR day my readers! My apologies for the low level of activity on this blog the last time. I’ve been very busy with MDR and IVDR work. And of course I have been working hard on the second edition of the big book, the Enriched MDR and IVDR, which is nearing completion and will […]
It had been been in the works for some time, although it also seemed unlikely for quite some time that this would happen. The implementation of the IVDR had been the slow little, neglected sister of the MDR implementation with greatly insufficient notified body capacity becoming available, and crucial elements of regulatory infrastructure (like the […]