As a tissue processor and medical device manufacturer, RTI Surgical (RTI) maintains a Quality Assurance Program in compliance with applicable federal and state regulations, as well as voluntary standards.
View a complete list of our credentials.
- RTI is accredited by the American Association of Tissue Banks (AATB) for processing, storage and distribution of skin, pericardium and musculoskeletal tissue for transplantation and research.
- RTI is registered as a Tissue Establishment with the Food and Drug Administration (FDA).
- RTI is registered as a Medical Device Manufacturer with the FDA.
- RTI’s quality system is certified to ISO 13485:2003 (with CMDCAS for Canada) Medical Devices Quality Management Systems.
- RTI is registered with Health Canada for Human Cells, Tissue and Organs for Transplantation (CTO).
- State Tissue Bank Licensure includes:
- New York
- Other state registrations as applicable: Delaware, Illinois and Oregon
- RTI is licensed as a Medical Device Manufacturer with the State of Florida.
- RTI Biomedical Laboratory:
- FDA Registration
- Clinical Laboratory Improvement Amendments (CLIA) Certificate of Compliance (Federal)
- State of Florida Clinical Laboratory Licensed