ISO 13485 is a standard specifically developed by ISO (International Organization for Standardization) for medical devices and equipment. This international standard specifies requirements to improve the performance of the Quality Management System to consistently deliver quality medical devices and related services. It helps organizations comply with customers as well as applicable regulatory requirements. Furthermore, the requirements of ISO 13485 not only apply to medical devices and equipment, but also apply equally to the associated services provided by the organization. iso 13485 peru