With the advancement of technologies leading to a shift in how healthcare is administered and delivered, software has become an essential component of the development of medical devices. Particularly “Stand alone” software or “Software as a Medical Device (SaMD)” has seen fast growth recently as there is no hardware involved, fewer constraints as well as the use of fast feedback loops for improvement. Part 1 of this publication series from IQVIA – an associate member of AdvaMed – explores SaMD definition, its challenges and the ways the regulatory bodies try to address them, as well as the expected development of regulations related to Artificial Intelligence (AI) and Machine Learning (ML) in SaMD.