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 the last meeting in Nice, France of 19-21 March gives us a peek into what is happening. Standalone software The new work items were interesting to me. IMDRF will start work on international harmonization of the approach to standalone medical device software and on the definition of common data elements describing medica [...] « Read the rest of this article on medicaldeviceslegal »