ETHOS Guidance - Clinical Safety Case Report from a Medical Device File

ETHOS offers specialised guidance on creating Clinical Safety Case Reports for medical devices, particularly focusing on software as a medical device. This document provides a detailed roadmap for manufacturers, ensuring compliance with the DCB0129 standard, which governs the clinical risk management in the development and maintenance of Health IT Systems. By following this guidance, manufacturers can systematically document the clinical safety aspects of their devices, from hazard identification and risk evaluation to risk control and documentation. This structured approach ensures that Health IT Systems are safe for deployment and use in clinical environments, aligning with regulatory requirements and enhancing patient safety.