Compliance
clinical safety
Systematic management of risks that could cause patient harm.
Definition
The systematic management of hazards, risks and mitigations related to a technology's interaction with clinical care that could cause patient harm, including requirements for documented clinical safety management systems, compliance with NHS clinical safety standards (e.g., DCB0129/DCB0160), and evidence of safe operation throughout the product lifecycle.
Related Terms
validation
Clinical validation of AI models....
Total Product Lifecycle (TPLC)
The full lifecycle from conception through post-market monitoring....
safety testing
Systematic evaluation of models for harmful capabilities pre- and post-deployment....
CE-marked medical device AI
AI that qualifies as a CE‑marked medical device under EU MDR/IVDR....
Software as a Medical Device (SaMD)
Software intended for medical purposes independent of hardware....