ISO 13485 is an international standard that represents the needs for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is based on the ISO 9001:2008 procedure model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory needs.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.