Glossary · Regulation
Software as a Medical Device
SaMD · medical device software · MDSW
Software as a Medical Device
RegulatorySoftware intended for a medical purpose that performs that purpose without being part of a hardware medical device.
The single most consequential classification in health software: it determines conformity assessment, clinical evidence and post-market duties.
Context
RelatedAI-enabled Medical Device, Intended Purpose, Clinical Decision Support System, Post-Market Surveillance
SourceIMDRF/SaMD WG/N12; MDCG 2019-11 Rev.1