International Regulatory Compliance Information
Quality Management System
| Production Quality Assurance FES motorized ergometers 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: |
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Canada
Medical device licenses: |
 | Europe Declaration of
Conformity (PDF format): Representative for regulatory affairs issues and incident reporting: Emergo Europe |
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Singapore
Declaration of Conformity (PDF format): |