List of relevant quality management and assurance system certifications for Coligne as the manufacturer of both ostaPek® 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.