Medical Devices & Software Validation ISO 13485 & ISO 80002 & IEC 62304 ISO 17025

The FMEA risk based software validation works of your products covered by the medical device are carried out by our company in accordance with FDA, ISO 13485, IEC/EN 62304, ISO80002 regulations. Providing ISO 13485 & IEC/EN 62304 compliance, production areas and used software, equipment qualification & validation studies are performed in medical device manufacturers. ERP, ORACLE, SQL DB data-data management system and software which are being used within the scope of quality continuity are validated by our experienced team. Within the scope of our approach; * Software used in Quality Management System * Software used in production equipment and management systems * Measurement and monitoring systems software * Software that manages the medical system * A part of the medical device, software for accessories * Qualifications of medical devices