International Regulatory Compliance Information
Quality Management System
| ISO 13485 quality system certification
ISO13485:2003 certificate Restorative Therapies, Inc is audited every year by: BSI Management Systems |  |
| United States US FDA Good Manufacturing Practice (GMP) We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. FDA 510(k)
cleared/PMA approved devices: |
 | Australia ABN 28 131 719 661 ARTG listings: Representative for regulatory affairs issues and incident reporting: Emergo Australia Pty. Ltd., Tel: |
 |
Canada
Medical device licenses: |
 | Europe Declaration of
Conformity (PDF format) CE Marking certificates Representative for regulatory affairs issues and incident reporting: Emergo Europe |
