EU AI Act – Consulting for Medical AI & Health Software

AI Regulation Consulting for MedTech

Our EU AI Act Compliance Services

• EU AI Act Gap Analysis
  Assess your current AI system’s compliance status with a structured EU AI Act gap analysis, identifying risks, documentation needs, and classification obligations.
• AI Risk Management System Development
  Design and implement a compliant AI risk management framework, aligned with the EU AI Act and harmonized with ISO 14971 for medical device risk management.
• AI System Classification & Regulatory Strategy
  Support in determining if your AI system qualifies as high-risk under the EU AI Act, with guidance on applicable artificial intelligence regulation pathways and technical documentation requirements.
• AI Transparency & Explainability
  Ensure compliance with AI transparency obligations, including clear and accessible documentation of model purpose, dataset characteristics, limitations, and decision-making logic.
• Data Governance & Dataset Quality
  Establish best practices for AI data governance across training, testing, and validation datasets—meeting EU AI Act and GDPR expectations for data accuracy, fairness, and representativeness.
• Technical Documentation Preparation
  Create audit-ready files covering your algorithm design, data management approach, performance testing, and validation metrics.
• Cross-Regulatory Integration
  Align your EU AI Act compliance strategy with ISO 13485, IEC 81001-5-1 (cybersecurity for health software), ISO 27001, EU MDR, IVDR, and GDPR.
• Conformity Assessment & Notified Body Preparation
  Guidance on preparing for Notified Body evaluations, including support with risk-benefit analysis, lifecycle monitoring plans, and post-market surveillance mechanisms.

Why Work With QMLogic as Your AI Compliance Consultant?

• MedTech-Focused Expertise
  We specialize in regulatory consulting at the intersection of AI, medical devices, and health software.
• Practical, Risk-Based Approach
  Our processes are efficient, actionable, and aligned with development timelines—balancing AI risk management with business needs.
• Future-Proof Compliance
  We stay current with changes to the EU AI Act and emerging frameworks like the NIST AI Risk Management Framework.
• Ethical AI & Transparency by Design
  We embed ethical, explainable, and trustworthy AI principles into your compliance strategy.

Who Must Comply with the EU AI Act?

• AI software used in medical devices, including those regulated under the EU MDR or IVDR
• AI used in clinical decision support, diagnostics, monitoring, and predictive health systems
• Developers, providers, and users of high-risk AI systems operating in or affecting the EU market

Structured Path to EU AI Act Compliance for MedTech

• AI System Evaluation
  Initial assessment to identify risks, classification, and data requirements.
• Risk Management Framework
  Develop risk controls in line with EU AI Act + ISO 14971.
• Data Governance Setup
  Ensure training/validation data is fair, representative, and well-documented.
• Transparency & Documentation
  Enable explainability and regulatory clarity through structured records.
• Lifecycle Monitoring
  Real-world performance tracking, post-market surveillance, and updates.
• Regulatory Alignment
  Harmonize with MDR, IVDR, ISO 27001, and GDPR for streamlined compliance.

EU AI Act Integration with Other Regulations

• EU Medical Device Regulation (MDR)
• In Vitro Diagnostic Regulation (IVDR)
• General Data Protection Regulation (GDPR)
• ISO 13485, ISO 14971, and IEC 81001-5-1