Compliance
Software as a Medical Device (SaMD)
Software intended for medical purposes independent of hardware.
Definition
Software intended to be used for one or more medical purposes regardless of the hardware on which it runs; classification and regulatory obligations are determined by the software's intended purpose and associated risk profile.
Related Terms
AI as a Medical Device (AIaMD)
SaMD that incorporates artificial intelligence or machine learning....
CE-marked medical device AI
AI that qualifies as a CE‑marked medical device under EU MDR/IVDR....
clinical safety
Systematic management of risks that could cause patient harm....
digital and data-driven health technologies
Software/systems using data analytics or automated decision-making in care....
Clinical decision support
AI tools that assist clinical decision‑making....