Access Risk Templates
EU AI Act Guide
ISO/IEC 42001 & NIST AI RMF

Rigorous AI Risk Standards

Technical compliance frameworks mapping international standards and medical-device-grade quality systems directly to your engineering workflows.

42001

ISO Management Standard

14971

Clinical Risk Standard

62304

Medical Software Lifecycle

Core Frameworks

Auditable Compliance Workflows

We translate high-level ethical principles into concrete, measurable engineering controls.

ISO/IEC 42001 (AIMS)

NIST AI RMF

ISO 14971 & IEC 62304

Establish a formal Artificial Intelligence Management System mapped directly to existing software development cycles.

Govern, map, measure, and manage AI risks with structured technical controls across the entire model lifecycle.

Apply clinical-precision risk mitigation and life-cycle management designed for high-risk and medical AI systems.

Framework Alignment

Standards Mapping Matrix

Compare international AI risk frameworks to align your internal quality management systems with upcoming global regulations.

ISO/IEC 42001

NIST AI RMF

ISO 14971 & IEC 62304

The foundational standard for establishing, implementing, and continuously improving an Artificial Intelligence Management System (AIMS) across an entire organization.

A flexible, non-regulatory framework focusing on practical technical controls to govern, map, measure, and manage AI system risks and trustworthiness.

Clinical-grade risk management and software lifecycle standards, providing the highest level of rigor for medical device AI and high-risk deployments.

Access Risk Templates

Deploy Auditable AI Systems

Download our medical-device-grade compliance checklists and risk registers to start aligning your workflows today.