The Essentials of Software as a Medical Device (SaMD)
Dot Compliance
FEBRUARY 8, 2022
To determine whether a particular software falls under the category of SaMD or whether it is considered a member of one of the three other subclasses, two questions must be answered: Does the software provide a direct medical benefit when used (correctly), and can it place the patient at risk if it is used incorrectly or malfunctions?
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