AI Regulation Consulting for MedTech
Ensure your AI-based medical software and health technologies align with the evolving EU AI Act. At QMLogic, we offer expert consulting to help MedTech and digital health companies navigate artificial intelligence regulations, build robust AI risk management frameworks, and ensure readiness for audits and conformity assessments.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?
The EU AI Act applies to: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
Our EU AI Act compliance framework is designed specifically for MedTech AI systems—ensuring risk-managed, transparent, and audit-ready solutions aligned with ISO, MDR, and GDPR requirements.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
The EU AI Act is not standalone, it intersects with multiple frameworks. We ensure your AI regulatory compliance aligns with:EU Medical Device Regulation (MDR)
In Vitro Diagnostic Regulation (IVDR)
General Data Protection Regulation (GDPR)
ISO 13485, ISO 14971, and IEC 81001-5-1
