A Step-by-Step Guide on Developing a SaMD Product

Software as a Medical Device (SaMD) is a medical software solution that can perform one or more medical functions without any need for a device itself. SaMD applications are intended to treat or prevent diseases and are typically used with non-medical hardware connected to virtual networks. SaMD popularity is now growing, and it has become widely used both for therapy and diagnostics. It has already developed into advanced technologies with the support of common operating systems, mobile devices, and cloud storage. It also must be compliant with healthcare industry regulations and guarantee the safety of patient information. The software must also support all the necessary infrastructure like research, testing, data collection & storage. This article will consider medical device software solutions and speak about their functionality and development process.