Clinical Evaluation of SaMD (Software as a Medical Device)

Clinical Evaluation of SaMD (Software as a Medical Device)

Software as Medical Devices have become an increasingly critical area for the Medical and Healthcare sector due to technological advancements. The software intended to be used as medical devices is regulated by the global regulatory authorities. The International Medical Device Regulators Forum (IMDRF) has released the guidelines for clinical evaluation of a SaMD (Software as a Medical Device) along with guidance on the Application of Quality Management system (QMS) and Risk Categorization for SaMD (Software as a Medical Device). Software as a Medical Device Working Group has established the regulatory pathway for the goal, strategy, principles, and concepts along with the implementation pathway for a harmonized SaMD framework.