The FDA published the final guidance for the clinical evaluation of software classified as a medical device (SaMD – Software as Medical Device).
The clinical evaluation should be understood as a continuous action belonging to the Medical Devices quality management system and aiming to ensure the designed software safety, effectiveness and performance.
The essential conditions for a correct clinical evaluation are the relationship between the software itself and a specific clinical condition, an analytical validation of input and output data processing, and the verification of the device clinical effectiveness during the course of therapy.
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