Alright! Now the MDR is here and nobody really has any clue on how to classify software. Well, we consultants typically pretend to understand it but the truth is, if you ask multiple consultants, you just get lots of different answers (and bills). But now the MDCG has released a guidance document on MDR medical device classification […]| OpenRegulatory
The complete walkthrough: MDR class I example devices, where to found your company (not in Berlin!), how much it costs and how long it takes.| OpenRegulatory