Our clinical governance framework ensures that every interaction meets the highest standards of patient safety, with comprehensive oversight at every level.
Medelic operates under a comprehensive clinical governance framework designed specifically for AI-assisted healthcare. Our approach combines continuous automated monitoring with expert human oversight.
Every clinical pathway in our system has been developed in collaboration with practising GPs, validated against NICE guidelines, and reviewed by our Clinical Advisory Board before deployment.
We maintain detailed audit trails of all clinical decisions, enabling retrospective review and continuous improvement of our safety protocols.
100% identification rate for clinical red flags, with immediate escalation protocols and automatic alerts to duty clinicians.
All triage pathways built on current NICE clinical knowledge summaries and updated within 48 hours of guideline changes.
Every clinical recommendation is reviewed by a qualified clinician. AI assists but never replaces professional judgement.
Our Clinical Advisory Board comprises senior clinicians, patient safety experts, and healthcare leaders who provide independent oversight of our clinical governance practices.
Chair
Former Chief Medical Officer, NHS England
Member
GP Partner, Primary Care Safety Lead
Member
Professor of Medical Informatics, UCL
Member
Patient Representative, Healthwatch
Continuous automated monitoring of all system outputs with anomaly detection algorithms trained on millions of clinical interactions.
Clear, tested escalation protocols ensure urgent cases are immediately routed to appropriate clinical resources.
Comprehensive audit capabilities enable retrospective review and continuous improvement of clinical safety.
Medelic is registered with the MHRA as a Class I medical device under UK MDR 2002, with appropriate quality management systems in place.
Our quality management system is certified to ISO 13485:2016, the international standard for medical device quality management.
Full compliance with DCB0129 Clinical Risk Management standard, including comprehensive hazard logs and clinical safety case documentation.
Meets all requirements of the Digital Technology Assessment Criteria, the NHS baseline standard for digital health technologies.
Our clinical processes are designed to support GP practices in meeting their CQC requirements for safe, effective, and well-led services.
Full compliance with NHS Data Security and Protection Toolkit (DSPT) requirements, independently verified annually.
We maintain robust incident management procedures aligned with NHS Serious Incident Framework requirements. Any adverse events are investigated thoroughly with findings shared transparently with affected practices.
Our clinical safety team conducts root cause analysis on all incidents, with learnings incorporated into system improvements and shared with our Clinical Advisory Board.
We report to the MHRA as required and maintain open communication with relevant regulatory bodies throughout any investigation process.
Initial Assessment
Incident triaged and clinical safety team notified
Practice Notification
Affected practice informed with preliminary findings
Root Cause Analysis
Full investigation completed with contributing factors identified
Remediation Complete
System improvements deployed and verified
We're happy to walk you through our clinical governance framework in detail. Book a briefing with our clinical team.