QUALITY MANAGEMENT SYSTEM:
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.
PRODUCT CERTIFICATIONS AND APPROVALS:
UNITED STATES – FDA 510(k) cleared/PMA approved device (link).
EUROPE – Declaration of Conformity (PDF format).
AUSTRALIA – Device listed in ARTG (link).
GLOBAL REGULATORY REPRESENTATIVES:
Shown below are in-country representatives for regulatory affairs issues and incident reporting.
EUROPE – Authorized Representative
Emergo Europe, The Hague, Netherlands
AUSTRALIA – Sponsor Representative
Emergo Australia, Sydney, Australia