Business comes at you fast. Just when you might be starting to embrace software-as-a-service and recognizing that hardware-as-a-service or equipment-as-a-service is a thing at all, software-as-a-medical-device (SaMD) enters the equation. SaMD is a specific category of medical technology that has gained significant attention in recent years, particularly from regulatory bodies like the FDA. Here’s a comprehensive overview:

Definition: SaMD is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”