Software as a Medical Device (SaMD)
What is Software as a Medical Device (SaMD)? Software as a Medical Device (SaMD) refers to standalone software designed for medical purposes, such as diagnosis, prevention, monitoring, or treatment of disease that operates without being embedded in hardware. Defined by the International Medical Device Regulators Forum (IMDRF), SaMD includes digital tools like AI diagnostic software, clinical decision support systems, and remote monitoring apps. […]
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