SaMD / SiMD

A Software as a Medical Device (SaMD) is a “software intended for one or more medical purposes that perform those purposes without being part of a hardware medical device,” as defined by the International Medical Device Regulators Forum (IMDRF).

A Software that is used to power hardware or drive a hardware device does not meet the criteria for SaMD and is known as Software in a Medical Device (SiMD).