- The Quality Management System of Saint Côme Chirurgie has been found to conform to the Quality Management System Standard ISO 13485: 2003.
- The certificate issued by DET NORSKE VERITAS (DNV) is valid for "Design, Manufacturing and Sales of sterile endoprosthesis (stents), intravascular catheters and associated devices".
- All the products comply with the applicable essential requirements of the Directives 93/42/EEC and 2007/47/EC.
- All the Saint Côme products have the authorization to apply the CE mark
(DNV – identification number CE 0434)
- Review and Auditing each year.
