AI & SaMD Quality Management System

What This Service Covers

Quality management system design for AI-enabled and SaMD products
Integration of AI lifecycle controls within ISO 13485-based QMS
Governance of algorithm development, training, validation, and change
Risk management for AI and software across the product lifecycle
Post-market performance monitoring and feedback into the QMS
Alignment of AI governance with regulatory and quality expectations

When This Service Is Typically Required

Developing or commercializing AI-enabled medical devices or SaMD
Scaling software or AI products into regulated markets
Addressing regulatory expectations for algorithm changes and updates
Integrating AI governance into an existing medical device QMS
Preparing for regulatory review or inspection of AI-based products

Applicable Regulations & Standards

ISO 13485
ISO 14971
IEC 62304
IEC 62366-1
ISO/IEC 42001
Applicable FDA and EU regulatory guidance for SaMD and AI

How This Fits Within the Quality System

This service embeds AI and SaMD controls directly into the quality management system, ensuring software and algorithm lifecycle activities are governed through existing QMS processes.

AI risks, changes, and post-market performance are managed as quality system elements rather than standalone technical or regulatory activities.

Contact

Engage with us to define an AI or SaMD quality system aligned to your product, technology, and regulatory strategy.