Software as a Medical Device (SaMD)

What is (SaMD)?

Software as a Medical Device (SaMD) comprises software independently serving one or more medical purposes without integration into hardware medical devices. It plays a crucial role in diagnosing, treating, monitoring, or managing diseases, providing health information, or aiding healthcare professionals. The United States Food and Drug Administration (FDA) regulates SaMD due to its significant impact on healthcare.


SaMD finds diverse applications in healthcare, including diagnosis, treatment, monitoring, and management of patient care. Its capabilities include analyzing medical data, controlling medical devices, tracking patient health, and aiding healthcare professionals in decision-making.

Benefits . . .

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