Quality management according to ISO standards
All our products are developed and produced according to our quality management system that complies with ISO 13485. Our processes are regularly audited by the notified body BSI and inspected by competent authorities such as the US Food and Drug Administration (FDA).
• BSI CE 00353 EC Certificate Exp. 2024-05-26
• BSI MD 81731 ISO 13485:2016 Quality Management System Exp. 2023-10-05
• BSI MDR 717177 R000 EU Quality Management System Exp. 2025-04-08
• BSI MDSAP 687164 ISO 13485:2016 Quality Management System Exp. 2021-10-05