• Sven Jungmann

Software as a Medical Device

“Software as a Medical Device,” or SaMD, refers to a software product that is intended for medical purposes but is independent from “hardware” or physical medical devices (e.g., thermometers, X-ray machines, artificial hearts, etc.). While SaMDs are generally used in combination or interfaced with other products, they are not essential to the functioning of other physical medical devices. SaMDs are considered medical devices for regulatory purposes, they run on general-purpose computing platforms, and they can include mobile apps that meet the defining criteria of a medical device.

Source: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf

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