Category - IMDRF


IMDRF Software as Medical Device definition document completes

In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number of other documents, after it was adopted at the meeting n Brussels 12-14 November 2013. People that commented on the document will remember that  the […]


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 […]