Definition and Regulatory Scope of SaMD

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2025-12-22 11:18:19 -

Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device. Unlike "Software in a Medical Device" (SiMD), which drives hardware (like the firmware in a pacemaker), SaMD is a standalone asset that can run on...

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