ISO 13485 is an international standard for the quality management system of medical devices. It outlines the requirements for organizations involved in the design, development, production, installation, and servicing of medical devices. ISO 13485 provides a framework for organizations to establish and maintain a quality management system that ensures the safety and effectiveness of medical devices. It covers various aspects such as risk management, regulatory compliance, design and development, production and control, and customer feedback.
Compliance with ISO 13485 is often a regulatory requirement for medical device manufacturers and suppliers, demonstrating their commitment to quality and regulatory compliance. It helps organizations improve their processes, enhance customer satisfaction, and ensure the safety and effectiveness of medical devices.
