ISO 13485:2003 standard defines the necessary quality management system requirements for equipment producers and other workers in health industry.

ISO 13485 Medical Devices Quality Management System is developed to implement EN46000 standards together with ISO 9001:2000 Quality Management Systems.

System’s aim is to organize the producers, distributors, exporters and importers and all corporations providing these services. The system is computable with EU medical Equipments Directives and is implemented with CE Mark.