Software as a Medical Device
Software as a Medical Device (SaMD) refers to software intended for medical purposes that performs these functions without being part of a hardware medical device. It includes applications for diagnosis, treatment, prevention, or monitoring of diseases, and is regulated as a medical device by agencies like the FDA and EMA. Examples range from mobile apps for diabetes management to AI algorithms for radiology image analysis.
Developers should learn about SaMD when building healthcare software that directly impacts patient care, as it requires compliance with strict regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485) to ensure safety and efficacy. This is crucial for applications in telemedicine, clinical decision support, or wearable health tech, where software errors could harm patients.