Xeltis’ Eindhoven facilities have been recognized as complying with the requirements of ISO 13485:2003 and EN ISO 13485:2012 for the design, development and manufacture of sterile bioabsorbable cardiovascular implants. The extended certification demonstrates Xeltis’ commitment to upholding the vigorous manufacturing standards that the ISO certification demands. “Xeltis’ ISO certification confirms the progress of our development process and is an additional, instrumental step on the roadmap towards CE marking of our pulmonary valve,” commented CEO Laurent Grandidier.

BSI QMS ISO 13485 Certification