Software as a Medical Device: Design and Compliance

The role of software in medical devices has changed dramatically, whether as a standalone device, an integral component of a medical device, or a mobile application. Patient safety is still of the highest priority in the rapidly changing field of Software as a Medical Device (SaMD). Regulatory standards for SaMD must consider all factors that influence its design and implementation. The definition of SaMD is still unclear, though, with different groups and scholars providing varying interpretations. This absence of a precise, uniform definition makes regulatory work more difficult and raises possible concerns for patient safety. In order to define the boundaries of SaMD, this study conducts a scoping review in order to identify and elucidate important concepts. Setting these limits is crucial to the responsible use of new technologies in healthcare, especially when it comes to assisting with service delivery and monitoring. The results of the study highlight how important it is to define SaMD precisely in order to effectively regulate new healthcare technologies and promote further innovation in the area.