Our quality and regulatory mission is to design, implement and support quality management systems for global medical manufacturing sites to assure regional, national and international regulatory compliance.

  • Our quality systems are compliant with CFR Part 820 and
    certified to ISO:13485:2003.
  • We have over 600 employees dedicated to quality assurance.
  • Our facilities are registered in compliance with national and
    international regulations.


C-TPAT Certification                          ISO 14001 Certification                   OHSAS 18001 Certification    




 ISO 9001                                EN ISO 13485 Certification