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The design, manufacture and distribution of our implants comply with the current French and European legislation, based on 3 concepts:

• Recognition, by the Health Ministry, of the service we provide with our implants, witnessed by their use in the healthcare system in France.
• Conformity with requirements in the area of safety and performance as defined in European Council Directives 93/42/EEC and 2007/47/CE concerning medical devices and certified by the CE marking.
  
  
  • Download CE certificate Appendix II 2009 (format .pdf)
  • Download EN-ISO 13485 certificate (format.pdf)
  • Download certificate for category III Cineos® (format .pdf)
  • Download certificate for category III Mobility® (format .pdf)
  • Download certificate for category III Novium® (format .pdf)
  • Download certificate for category III KAPS® (format.pdf)
  • Download certificate for category III T.KAPS® (format.pdf)
  
  
• Materiovigilance, subject to European regulations, whose purpose is to prevent the occurrence or recurrence of serious incidents and the risk of serious incidents caused by our implants, by taking the appropriate preventive and/or corrective measures.

Our Quality Process

In addition to this legislation, X.NOV has implemented an ISO 13485 certified quality management system to ensure that the needs of our clients are fulfilled and the regulatory requirements are satisfied.