REGULATORY

Clariance’s Quality Management System is certified ISO 13485:2003.

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: “design, development, manufacture and marketing of implantable devices and instruments for spinal surgery”. It is also fully compliant with Council Directive 93/42/EEC on medical devices. Download ISO 13485 certificateDownload EC certificate