ISO 42001 Integration for Medical Devices

What This Service Covers

Integration of ISO/IEC 42001 AI management system within medical device QMS
Alignment of AI governance requirements with existing ISO 13485 systems
Definition of AI-specific policies, controls, and accountability structures
Risk and performance monitoring aligned to AI lifecycle requirements
Harmonization of AI management with regulatory expectations

When This Service Is Typically Required

Organizations implementing AI management systems alongside medical device QMS
Expansion into AI-enabled products requiring structured governance
Alignment of AI practices with emerging regulatory and standard expectations
Integration of standalone AI controls into a regulated QMS environment

Applicable Regulations & Standards

ISO/IEC 42001
ISO 13485
ISO 14971
IEC 62304
Applicable AI regulatory guidance (FDA, EU)

How This Fits Within the Quality System

ISO 42001 controls are integrated into the QMS structure, ensuring AI governance operates within existing quality system processes rather than as a parallel management system.

Contact

Discuss integration of ISO 42001 within your existing quality system and regulatory framework.