At Swibrace, we place fundamental importance on the quality, security and regulatory compliance of our solution. Our solution is based on a rigorous quality process. Our 3D printers are specifically validated for orthotic production. In accordance with European Regulation (EU) 2017/745 (MDR), our orthoses are recognised as Class I medical devices and have a European certificate of conformity. Each patient receives validated instructions for use, and can anonymously send us any feedback or reports concerning the use of the device. We continuously monitor regulatory developments and good practice in the field of medical additive printing. Swibrace splints are approved for sale in Switzerland and the European Union (our European representative is the company
Medicina Legatis).