AI Governance within Medical Device QMS

What This Service Covers

Integration of AI governance controls within ISO 13485-based QMS
Definition of roles, accountability, and decision authority for AI systems
Governance of training data, model development, validation, and deployment
Alignment of AI lifecycle activities with risk management and design controls
Establishment of controls for transparency, traceability, and auditability

When This Service Is Typically Required

Development of AI-enabled medical devices requiring regulatory oversight
Integration of AI components into an existing medical device QMS
Preparing for regulatory scrutiny of AI governance and lifecycle controls
Addressing gaps in accountability and control over AI-driven functionality

Applicable Regulations & Standards

ISO 13485
ISO 14971
ISO/IEC 42001
IEC 62304
Applicable FDA and EU guidance on AI/ML-based SaMD

How This Fits Within the Quality System

AI governance is embedded as a controlled layer within the QMS, ensuring that algorithm development, validation, and changes are managed through established quality system processes, rather than treated as isolated technical activities.

Contact

Engage with us to establish AI governance aligned to your product architecture and regulatory expectations.