ISO 13485 is the international standard for medical device quality management systems. The term “medical device” covers a wide range of products, including medical equipment, surgical instruments, in vitro diagnostic products, cosmetics, and patient monitoring systems used in the diagnosis or treatment of disease. ISO 13485 is applicable to both stand-alone organizations and to any organization providing contract manufacturing or other services to medical device manufacturers. ISO 13485 is not the design control standard for medical devices.