Clinical AI Governance That Protects Patients
Clinical AI sits at the intersection of MDR and the EU AI Act — two regulatory frameworks with overlapping but distinct requirements. We unify them in one workspace so your diagnostic AI, clinical decision support, and patient monitoring systems are governed against both. Patient safety and regulatory compliance, from the same source of truth.
Your Workflow, Step by Step
Here's how you govern clinical AI across MDR and the EU AI Act
Register Clinical AI Systems
Catalog every clinical AI system — diagnostic imaging, clinical decision support, patient monitoring — with their MDR classification and EU AI Act risk tier in one registry.
Score Against MDR + AI Act
Each clinical AI system gets a 5-dimension TRACE score mapped to both MDR essential requirements and EU AI Act obligations. One assessment, two frameworks satisfied.
Build Inspection-Ready Evidence
Merkle-chain verified evidence trails for every clinical AI decision. When the notified body or market surveillance authority asks, your documentation is already complete.
Monitor Post-Market AI Performance
Continuous TRACE scoring tracks clinical AI performance in production. Detect compliance drift before it becomes a patient safety incident or a regulatory finding.
136days until enforcement
Protect Patients. Satisfy Regulators.
Govern your clinical AI against MDR and the EU AI Act from one workspace. Evidence that notified bodies trust, built automatically.