Software as a Medical Device, often shortened to SaMD, refers to software intended for a medical purpose that is not part of a hardware medical device. Some healthcare AI products may need regulatory review depending on intended use, claims, users, and workflow.
Buyers should not infer regulatory status from marketing language; intended use, labeling, validation, and local regulatory review matter.
Application scenario: In workflow review, this term helps teams map a vendor claim to the care setting, data flow, integration point, user handoff, and oversight step where it applies. Procurement impact: Buyers should evaluate evidence, interoperability effort, security and privacy controls, pricing assumptions, support, and compliance responsibilities before shortlisting or contracting for a tool that depends on this capability.