Quality Management System
ISO 13485 Quality System Certification
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our establishment registration on the FDA website.
Notified Body
Christie Medical Holdings, Inc. maintains ISO 13485:2016 certification and is audited every year by:
TÜV SÜD Product Service GmbH
Ridlerstraße 65
80339 München, Germany
Product Certifications and Approvals
EN ISO 13485:2016 Certificate
Canada-Medical Device License
Europe-CE Marking Certificate
Global Regulatory Representatives
Shown below are in-country representatives for regulatory affairs issues and incident reporting.
AUSTRALIA – Sponsor Representative
Emergo Australia, Sydney, Australia
Telephone: +61.2.9006.1662
http://www.emergogroup.com/services/australia/australia-tga-sponsor
BRAZIL – ANVISA Registration Holder
Emergo Brazil, Brasilia, Brazil
Telephone: +55 61 3386 3166
http://www.emergogroup.com/services/brazil/brazilian-registration-holder
EUROPE – Authorized Representative
Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570
http://www.emergogroup.com/services/europe/european-authorized-representative
