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
CANADA- Medical device licenses
RT300
Live data from Health Canada website
EUROPE - CE Marking certificates
RT300
EUROPE - Declarations 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