Category - Accessories


IMDRF invites comments on standalone software key definitions

As announced, the IMDRF is on the case for software, which shows how important this subject is becoming in the medical devices field. I  notice this everyday in my medical devices practice, as more and more medical devices software work comes in. That is great for me, as I grew up around software engineers in […]


Happy New Year – with all those developments

The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will not be the usual regulatory and legal analysis of rules, but something more forward […]