Credentials

As a tissue processor and medical device manufacturer, RTI Biologics (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:
    • Florida
    • Maryland
    • California
    • 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
    • New York State Department of Health Clinical Laboratory Permit
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