What is the purpose of ISO 13485?

The purpose of ISO 13485 is to define quality management system requirements specifically for organizations involved in designing, developing, producing, and servicing medical devices. This standard provides a framework for ensuring that products consistently meet customer and regulatory requirements, which is vital in the medical device industry, where the safety and effectiveness of devices are paramount.

ISO 13485 emphasizes the importance of a systematic approach to managing processes and documentation that affect quality. It encompasses various elements such as risk management, design control, and process validation, which are crucial for organizations to ensure that they produce safe and effective medical devices. By adhering to these quality management principles and requirements, organizations can not only enhance customer satisfaction but also facilitate regulatory compliance and improve overall operational efficiency.

This strong focus on quality management distinguishes ISO 13485 from the other options, which involve different aspects of medical devices, such as advertising claims, clinical trial standards, and general safety standards in manufacturing, which are not the primary purpose of ISO 13485.