GluStitch Inc. offers an unconditional performance guarantee that all products will perform in accordance with each intended use. The Quality Management System at GluStitch Inc complies with Good Manufacturing Practices and complies with internationally recognized standards, such as ISO 13485:2003 and Annex II of the European Union Medical Device Directive and undergoes regular surveillance audits, performed both internally and via independent inspectors, to ensure Quality System compliance. GluStitch Inc. has met all requirements for CE Marking and holds valid EC Certificates.