End-to-end governance for AI-enabled and software-driven medical devices — integrating algorithm lifecycle controls, software development processes, and post-market monitoring into a single QMS.
What this covers
QMS design for AI-enabled and SaMD products, integrated with ISO 13485
Governance of algorithm development, training, validation, and change
End-to-end lifecycle control — requirements, risk, verification, validation
Control of software releases, updates, and version management
Definition of roles, accountability, and decision authority for AI systems
Post-market performance monitoring feeding back into the QMS
When this is typically needed
Developing or commercializing AI-enabled medical devices or SaMD
Scaling software or AI products into regulated markets
Transitioning from non-regulated software development to medical-grade process
Addressing regulatory expectations for algorithm changes and updates