Regulatory

Our field of activity moves forward relentlessly with the development of new technologies, new standards and constantly higher customer expectations. Consequently, we have set up a Quality Management System that enables us to endlessly improve the quality of our products. All our products are validated during the development phase, the manufacturing process and obviously, during clinical practice. Our Quality Management System has been certified ISO 13485:2003, a standard for: “Medical devices — Quality management systems —Requirements for regulatory purposes”. It is also fully compliant with Council Directive 93/42/EEC on medical devices.