International Regulatory Compliance Information
QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system
certification
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
AUSTRALIA
Devices listed in ARTG RT300 on TGA website
ABN 28 131 719 661
CANADA- Medical device licenses
RT300
Live data from Health Canada website
EUROPE - CE Marking certificates
RT300
EUROPE - Declaration of
Conformity (PDF format)
RT300
UNITED STATES - FDA 510(k)
cleared/PMA approved devices (Links
to US FDA database device listing)
RT300:
K060032 K050036 K071113 K071486 K072398
GLOBAL REGULATORY REPRESENTATIVES
Shown below are our in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here.
AUSTRALIA -
Sponsor Representative
Emergo Australia Pty. Ltd., Sydney,
AUSTRALIA
Telephone:
http://www.EmergoGroup.com
EUROPE -
Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone:
http://www.EmergoGroup.com
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
Restorative Therapies, Inc maintains
ISO 13485:2003 certification
and is audited every year by:
BSI Management Systems
12110 Sunset Hills Road,
Suite 200, Reston, VA, 20190
USA