
International Regulatory Compliance Information
QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification (PDF format)
ISO 13485:2003 certificate
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
PRODUCT CERTIFICATIONS AND APPROVALS
CANADA- Medical device licenses (Links to Health Canada website)
EUROPE - CE Marking certificates (PDF format)
EUROPE - Declarations of Conformity (PDF format)
UNITED STATES - FDA 510(k) cleared/PMA approved devices (Links to US FDA database device listing)
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
http://www.EmergoGroup.com
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
ABC Medical Devices maintains ISO 13485:2003 certification and is audited every year by:
AAA Auditing Services
Anytown, USA
Telephone: +1.555.555.1234
Website link
