Although the use of software in healthcare has existed since the ‘90s to assist medical practitioners in key areas such as diagnostics and patient monitoring, it wasn’t until the 2010s that Software as a Medical Device (SaMD) became a standardized industry term, formalized by the International Medical Device Regulators Forum (IMDRF), with development expectations established through international standards and regulatory guidance.
Despite the proximity and common terminology, Software as a Medical Device (SaMD) should not be confused with Software in a Medical Device (SiMD). Unlike SiMD, which is embedded in traditional medical devices and controls the hardware’s functionality, SaMD performs its medical purpose without being part of or controlling a hardware medical device. It may still run on general-purpose platforms (e.g., smartphones, servers) and process data coming from medical equipment.