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…


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 ┬ánotice this everyday in my medical devices practice,…


What's cooking at IMDRF? UDI and software, among other things

After the GHTF had been decommissioned – much to the disappointment of many – the IMDRF had big shoes to fill and everybody is watching if they manage. The outcome statement of…

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