ETHOS provides expert guidance and support for clinical safety through structured hazard assessment workshops, aimed at ensuring the safety and compliance of digital health products. This document outlines a comprehensive approach to conducting a Clinical Safety Hazard Workshop, detailing the necessary preparations, roles, and steps involved in the assessment process. By following this guide, organisations can effectively identify, discuss, and mitigate potential hazards associated with the implementation and use of clinical systems, ensuring they meet the rigorous standards required for patient safety and regulatory compliance.

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