Trusted AI Governance
Trusted AI Governance
Medical device compliance, clinical AI validation, and patient safety governance. We help healthcare organizations deploy AI that satisfies FDA, MHRA, MDR, and ISO 13485 requirements.
Healthcare AI carries unique liability—diagnostic errors, treatment recommendations, patient safety incidents. Regulatory expectations are higher, evidence standards are stricter, and the cost of failure is measured in lives, not just fines.
Healthcare organizations face regulatory requirements that don't exist in other sectors. Medical device regulations (MDR, IVDR, FDA 510(k)), clinical validation standards (ISO 13485, ISO 14971), patient safety obligations (HIPAA, GDPR Article 9), and professional liability considerations create a governance landscape that generic AI consultancies don't understand.
AI systems that diagnose, recommend treatment, or influence clinical decisions are medical devices. They require validated quality management systems, clinical evidence, post-market surveillance, and adverse event reporting.
Integrated governance for medical device and clinical AI systems
Design AI Management Systems that integrate with existing ISO 13485 Quality Management Systems. Avoid duplicate documentation, align risk management processes, satisfy both medical device and AI-specific requirements.
Establish clinical validation protocols meeting MHRA/FDA evidence standards. Design retrospective and prospective studies, define performance metrics, document validation results, prepare regulatory submissions.
Prepare AI-based medical devices for CE marking under MDR/IVDR. Article 52 software qualification, Annex I essential requirements, clinical evaluation reports, technical documentation packages.
Govern AI processing of protected health information (PHI) and special category health data. Access controls, audit trails, data minimization, patient consent mechanisms, breach notification protocols.
Design post-market surveillance systems meeting MHRA/FDA requirements. Performance monitoring, bias detection, safety signal identification, adverse event reporting, periodic safety update reports (PSURs).
Apply ISO 14971 risk management to AI systems. Hazard identification for AI-specific risks (bias, drift, explainability failures), risk controls, residual risk acceptability, risk-benefit analysis.
Specialized governance for clinical AI across the care continuum
Diagnostic Imaging AI — Radiology, pathology, dermatology AI systems. Clinical validation, FDA 510(k) or MDR Class IIa/IIb conformity, performance monitoring, radiologist override protocols.
Clinical Decision Support Systems — Treatment recommendation engines, drug interaction alerts, sepsis prediction. Evidence-based validation, clinician override mechanisms, adverse event tracking.
Patient Triage & Symptom Checkers — AI-powered triage systems, symptom assessment chatbots. Transparency requirements (GDPR Article 22), safety guardrails, escalation protocols, informed consent.
Predictive Analytics — Patient deterioration prediction, readmission risk models, population health AI. Bias testing across patient demographics, clinical validation, integration with clinical workflows.
Medical Devices with AI — Insulin pumps with predictive algorithms, surgical robots with autonomous features. MDR Annex I compliance, safety risk controls, cybersecurity validation.
Administrative AI — Prior authorization automation, claims processing, revenue cycle AI. HIPAA compliance, bias testing (denial rates by demographics), audit trail requirements.
Client: Medical imaging company developing AI-powered diagnostic tools for radiologists. Needed ISO 42001 certification to satisfy enterprise healthcare buyers without disrupting ISO 13485 compliance.
Result: 3 AI systems certified, 14 weeks gap-to-certification, 100% Stage 2 audit pass, integrated with ISO 13485/MDR without workflow disruption, £52K investment
Whether you're developing diagnostic AI, clinical decision support, or patient-facing systems, we ensure your governance satisfies healthcare regulators and protects patient safety.
Get Started