Software as a Medical Device (SaMD): Transforming the Digital Frontier of Healthcare
In today’s technology-driven healthcare environment, Software as a Medical Device (SaMD) has emerged as one of the most revolutionary innovations. Unlike traditional medical devices that rely on physical components, SaMD functions entirely through software, enabling diagnosis, monitoring, or treatment without being part of a hardware medical instrument. It is redefining how clinicians, patients, and healthcare systems interact with digital tools to enhance medical outcomes.
Understanding 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 perform these functions without being part of a hardware medical device. This means SaMD can operate independently on computers, smartphones, tablets, or cloud platforms.
Examples include:
Software that analyzes MRI images to detect tumors.
