Quality Management Certifications

List of relevant quality management and assurance system certifications for Coligne as the manufacturer of both ostaPekĀ® cages and pedicle fixation systems.

ISO 13485 - MDSAP

ISO 13485:2016 MDSAP – Quality management system certification under MDSAP (Medical Device Single Audit Program) for the USA (21 CFR 820) and Canada (SOR/98-282).


EN ISO 13485

EN ISO 13485:2016 – Quality management system certificate.


EC-Certificate

EC-Certificate – Full quality assurance system certificate.