EN ISO 14971

EN ISO 14971 is an international standard that outlines the process for managing risks associated with medical devices. It provides guidelines for identifying potential hazards, evaluating the risks they pose, and implementing measures to reduce those risks to acceptable levels. The standard emphasizes continuous monitoring and reassessment throughout a device's lifecycle to ensure safety and effectiveness. By following EN ISO 14971, manufacturers can systematically improve their products and protect patients, thereby fostering trust in medical technology.