International Medical Device Regulators Forum Releases International Framework for Regulating Software as a Medical Device (SaMD)

In September 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations”. The IMDRF is the regulators-only successor group to the Global Harmonization Task Force (GHTF). Continue reading