Software as a Medical Device Webinar


In the middle of November, Auxergo joined a webinar on human factors considerations of software as a medical device (SaMD). SaMD is defined by International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. SaMD should be considered during the design and development process, as well as comply with relevant human factors regulations. These regulations are consistent with human factors regulations for medical devices, especially for the case of clinical evaluation and use-related risk assessment and control. Human factors processes for SaMD should be applied with the same rigour as for medical devices in general.



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