Service Fact Sheet: Software as a Medical Device
Information on regulations for software that qualifies as medical devices.
Software as a Medical Device (SaMD) is software that has the potential to prevent, diagnose, treat, or mitigate a disease or condition. It has emerged as a category of medical devices unto its own and has its own regulatory and compliance considerations that must be met.
Learn more about Intertek's end-to-end solutions to support SaMD from concept through commercialization.