Software as a Medical Device

**Semantic type:** Medical Device

**Definition:** Software intended to be used for the performance of one or more medical purposes, without being part of a hardware medical device. ("Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations Authoring Group: IMDRF Software as a Medical Device (SaMD) Working Group Date: 18 September 2014)

**Synonyms:** - SaMD - software as a medical device (SaMD)