ONEFIT medical has established a quality management system that allows it to sell medical devices in accordance with regulatory requirements and standards. The company is ISO 13485 certified and its medical devices are developed in accordance with the European Medical Devices Directive 93/42/EEC (2007). Its pre-operative planning software is currently being reviewed by the FDA for 510k certification.


ISO 13485 : 2003 and NF EN ISO 13485 : 2012

ISO 13485 : 2003 CMDCAS