Software as a Medical Device

 Software as a Medical Device (SaMD) refers to software intended to be used for medical purposes without being part of a physical medical device. It is designed to diagnose, prevent, monitor, treat, or manage medical conditions. SaMD plays a vital role in modern healthcare by enabling digital diagnosis, clinical decision support, and patient monitoring through computers, smartphones, and cloud-based as a Medical Device is defined as standalone software that performs medical functions on its own. Unlike traditional medical devices, SaMD does not require hardware components to operate. It runs on general-purpose platforms such as mobile phones, tablets, or computers and delivers healthcare-related outcomes.


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