Making AI Compliance Understandable
EU AI Act
AI Governance
AI Risk Management
AI Quality Managment
AI Compliance for Medical Devices
The Hub translates complex European artificial intelligence requirements into actionable technical guidance. We bring the EU AI Act, AI governance frameworks, risk management standards, and practical compliance roadmaps together in clear language built for engineering, legal, and risk leadership.
Trustworthy AI Hub brings these topics together in one place.
EU AI Act
AI Governance
AI Risk Management
AI Standards
Understand obligations, risk classification, requirements and compliance.
Build accountability, policies, roles and governance structures.
Identify, assess, mitigate and monitor risks throughout the AI lifecycle
Understand ISO, IEC, CEN and CENELEC standards supporting trustworthy AI
NAVIGATE AI COMPLIANCE
Explore the official technical standards establishing enforceable benchmark architectures for organizational quality management and lifecycle risk assessment.
prEN 18286 – AI Quality Management System
prEN 18228 – AI Risk Management
Requirements for AI Quality Management System (QMS) aligned with EU AI Act.
Framework for AI risk management and assessment across the AI lifecycle.
REGULATORY INTERSECTION
For medical device manufacturers, integrating artificial intelligence requires navigating a dual regulatory regime: aligning the EU AI Act’s high-risk obligations with established medical device quality, risk management, and conformity frameworks.
Quality Assurance and Regulatory Affairs teams do not need to build parallel compliance structures from scratch. By mapping EU AI Act Annex IV technical documentation requirements directly to ISO 13485 design history files and ISO 14971 risk management files, organizations can maintain a single source of regulatory truth.
Unified Technical File
ISO 13485 & Quality Systems
ISO 14971 & Risk Management
EU MDR & CE Marking
Leverage coordinated conformity assessment procedures so AI software (MDSW) satisfies both medical device clinical evaluation rules and high-risk AI system statutory requirements.
Harmonize QMS lifecycle controls with EU AI Act Article 17, ensuring data governance, model monitoring, and technical documentation seamlessly interlock with existing medical quality procedures.
Extend patient safety risk analyses to cover AI-specific hazards such as training data bias, algorithmic performance drift, and automated decision explainability throughout the product lifecycle.
Combining post-market clinical follow-up (PMCF) under EU MDR with continuous post-market monitoring under Article 72 of the EU AI Act reduces audit overhead and accelerates time to market.
AI Governance
AI Risk Management
AI Compliance
AI Lifecycle
Define roles, responsibilities, and oversight mechanisms for AI systems.
Implement continuous processes for identifying, assessing, and mitigating AI-specific risks.
Ensure adherence to statutory obligations, technical documentation requirements, and ethical guidelines.
Integrate governance and compliance throughout the entire AI system development lifecycle.
NEW TO AI COMPLIANCE?
Navigate the regulatory landscape with structured guides, classification frameworks, and essential standards for European AI compliance.
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