Proven Record of Safety
Quality Assurance
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.
- 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 License
- New York State Department of Health Clinical Laboratory Permit
All laboratory testing is performed using kits approved by the FDA for donor screening and cadaveric specimens, if applicable. Laboratory procedures comply with the kit manufacturer’s instructions for use regarding testing protocol, specimen type and specimen handling/storage requirements.
Accreditation and Certification
See a complete list of the company’s accreditations, certifications, registrations and licensures.
Tissue Processing
RTI Biologics processes four types of allografts—soft tissue, bone, bone paste/putty and membranes. Tissue processing is performed in certified ISO Class 5 to Class 7 clean rooms to prevent environmental contamination of the tissue.
RTI’s primary goal is to ensure patient safety. To fulfill this goal, RTI employs stringent donor screening, laboratory testing and tissue preparation validated to inactivate or remove pathogens. These redundant safeguards provide the highest level of confidence that patients will receive safe, high quality tissue.