The ISO 13485 standard is an international standard that specifies requirements for a quality management system applicable to the medical device industry. This standard is designed to be used by organizations involved in the design, production, installation, and maintenance of medical devices, as well as in the design, development, and provision of related services.
The objective of implementing a quality management system for medical devices according to the ISO 13485 standard is to ensure the safety and effectiveness of healthcare products. This is achieved through the standardization of processes, continuous improvement, and compliance with regulatory requirements. Additionally, it aims to increase customer satisfaction and reduce quality-related risks, ensuring that medical devices consistently meet applicable expectations and regulations.
