Software as a Medical Device

Software as a Medical Device (SaMD) refers to software that is intended to be used for one or more medical purposes and performs these purposes without being part of a physical medical device. Unlike traditional embedded software, SaMD runs on general-purpose platforms such as computers, tablets, or smartphones and plays a direct role in diagnosis, monitoring, prevention, or treatment of diseases.SaMD is widely used in modern healthcare for clinical decision support, diagnostic imaging analysis, patient monitoring, and digital therapeutics, making it a critical component of digital health ecosystems.Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as software intended for medical purposes that is not part of a hardware medical device. It operates independently and provides medical functionality through algorithms, data analysis, and clinical logic.
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