SaMD. Standalone Medical Devices. Do you have SaMD or software systems that might be classified as medical devices, even if FDA has chosen not to regulate them? Do you know the features that might trigger medical device classification? Whether regulated or not, a well developed and sufficiently documented risk analysis and management plan is essential and the first step toward safe products. Contact SoftwareCPR to help you with strategic feature planning and software architecture decisions for your SaMD to confidently navigate the SaMD highway.