Compliance Checklists and Templates

Operational Compliance Assets

Structured tools built to medical-device-grade precision to accelerate your conformity assessments and quality management system integration.

Annex IV Documentation Checklist

Clinical AI Risk Register Template

AI Risk Classification Decision Tree

A complete technical documentation checklist mapping directly to Annex IV requirements for high-risk AI systems under the EU AI Act.

A pre-formatted risk matrix integrating clinical ISO 14971 medical risk criteria with NIST AI RMF hazard categories.

Step-by-step logic map to determine if your system qualifies as High-Risk, GPAI, or Prohibited under the EU AI Act.

AIMS Quality Manual Outline

Enterprise AI System Inventory

AI Literacy Presentation Kit

An actionable outline for establishing an Artificial Intelligence Management System aligned with harmonized ISO/IEC 42001 standards.

A template to catalog, classify, and track AI deployments across your organization to ensure continuous regulatory readiness.

Slide deck and training materials to meet the mandatory AI literacy requirements for system operators and deployers.

Accelerate Your Compliance Timeline

Get instant access to our complete operational library, including the Annex IV checklist and medical-device-grade risk templates.