ISO 13485:2016 Medical Devices Management System CertificationISO 13485: 2016 Medical Devices Management System Certification Ensure Safety and Quality in Medical Devices What Does ISO 13485 Stand For? ISO 13485 stands for Medical Devices Quality Management Systems, an international standard developed by the International Organization for Standardization (ISO). It provides a globally recognized framework for establishing and maintaining a quality management system specific to the medical device industry. What Is