Quality Management

Quality Management System

Quality System Certificates
 
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.

FDA Establishment Registration Numbers:
 

Notified Body / Registrar / Certification Body

Merge Healthcare maintains ISO 9001 and 13485 certification and is audited every year by:
SGS United Kingdom Ltd.
  • ISO Registrar:  SGS United Kingdom, Cheshire, UK
  • Notified Body:  SGS United Kingdom, West Super-Mare, UK
SGS United Kingdom Website
 

Global Regulatory Representatives

Shown below are our in-country representatives for regulatory affairs issues and incident reporting.
EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570

AUSTRALIA - Sponsor Representative
Emergo Asia Pacific Pty Ltd, Sydney, AUSTRALIA
Telephone: +61 (0) 2.9006.1662