Clinical Safety Framework
MoleScan™ is committed to clinical safety. Our platform is designed with clinical safety as a foundational requirement, aligned with DCB0129 (manufacturer) and DCB0160 (deploying organisation) clinical risk management standards.
Dermatologist-Led Assessment
MoleScan is a dermatologist-led platform. Every assessment is initiated by a healthcare professional and reviewed by a UK GPwSI or dermatologist. The platform provides clinical decision support — it does not make autonomous clinical decisions.
The final clinical decision always rests with the referring practitioner. MoleScan provides structured evidence to support, not replace, clinical judgement.
Clinical Safety Officer
MoleScan maintains a designated Clinical Safety Officer (CSO) responsible for the clinical safety case, hazard identification and management, and clinical incident reporting.
Hazard Management
A clinical hazard log is maintained and reviewed regularly. Potential clinical hazards are identified, assessed, and mitigated through the clinical risk management process.
Incident Reporting
MoleScan operates a clinical incident reporting process. All clinical incidents are investigated, and findings are fed back into the clinical safety case and hazard log to drive continuous improvement.
Scope of Use
MoleScan is a clinical workflow and triage platform. It is not a diagnostic device. It supports practitioners in assessing and triaging skin lesions by providing structured clinical triage and UK GPwSI and dermatologist review. Final diagnosis requires clinical assessment and, where indicated, histopathological confirmation.
Contact
For clinical safety enquiries, contact us at hello@molescan.co.uk.