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Software as a Medical Device (SaMD)

What is (SaMD)?

Software as a Medical Device (SaMD) comprises software that independently serves 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.

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