Abstract: A method for monitoring a medical device (DM) available to a patient (P), the medical device (DM) including a communication terminal (T) implementing software functionalities (f1, f2, f3) for accompanying the patient (P) in a predetermined therapeutic treatment, the method including: —a step (S1) of receiving the current data (DC) on execution of the software functionalities (f1, f2, f3) coming from the medical device (DM), —a step (S2) of testing the current data (DC) by comparison with reference data (DR) according to at least one predetermined vigilance rule (R) associated with a risk for the patient, and —a step (S3) of sending a vigilance message (M1) when such a risk is identified.

Abstract: A method and device for generating a stream of data that is representative of at least an algorithm (44) of a software as a medical device. To reach that aim, the method comprises designing (41) the at least an algorithm using first programming language items of a determined domain-specific language (DSL), which is obtained using a determined language workbench (LWB) environment. The method further comprises simulating (42) an executing of the at least an algorithm with a simulation environment obtained using second programming language items of the determined DSL, the simulating being implemented in the determined LWB environment; testing (43) the at least an algorithm with at least a test function written with third programming language items of the DSL, the testing being implemented in the determined LWB environment; and generating (440) the stream of data.