Standalone Software Regulated As Medical Device: A Look Under The Hood Of The Draft MEDDEV

Sometimes you have to go far away to learn a lot about thing close to home and that is what happened to me at the RAPS Regulatory Convergence Conference that I am currently attending in Indianapolis. There was an interesting presentation of Gregory Martin from BSi Healthcare about the developments in EU med ical device law with respect to standalone software and I bumped into a bunch of other interesting people that I had chats with, and voila, I was able to reverse-engineer the following about the MEDDEV in the works on EU regulation of standalone medical devices software. More in general the conference has been very interesting and I have learned more than on many conferences I attended in the EU.