Quality Assurance

Quality Assurance

RTI management and employees are committed to maintaining a quality assurance program that effectively complies with applicable federal and state regulations, implements industry best-practices and ensures customer requirements are met.

  • RTI is accredited by the American Association of Tissue Banks (AATB) for processing, storage and distribution of cornea, sclera, skin, pericardium and musculoskeletal tissue for transplantation and research.
  • RTI is registered as a Tissue Establishment with the U.S. Food and Drug Administration (FDA).
  • RTI is registered as a Medical Device Manufacturer with the U.S. FDA.
  • RTI’s quality system is certified to ISO 13485:2016 (with CMDCAS for Canada) Medical Devices Quality Management Systems.
  • RTI is registered with Health Canada for Human Cells, Tissue and Organs for Transplantation (CTO).
  • RTI maintains state tissue bank licensure in:
    • Florida
    • Maryland
    • California
    • New York
    • Other state registrations as applicable: (Delaware, Illinois and Oregon).
  • RTI Biomedical Laboratory:
    • Clinical Laboratory Improvement Amendments (CLIA) Certificate of Compliance (Federal)
    • State of Florida Clinical Laboratory License

All infectious disease lab tests are performed using kits approved by the FDA for donor screening and cadaveric specimens, if applicable. Testing procedures comply with the kit manufacturer’s instructions for use regarding testing protocol, specimen type and specimen handling/storage requirements.

Accreditation and Certification

To view a complete list of RTI accreditations, certifications and licensures, click here.

Allograft Processing

RTI Surgical 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 minimize the probability of pre-processing environmental contamination of the tissue.

RTI’s primary goal is to maximize patient safety. To fulfill this goal, RTI employs stringent donor screening, laboratory testing and, wherever possible, 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.

Statement on Latex as it Relates to Allograft and Xenograft Implants

RTI’s implants do not contain latex and are not packaged in or with materials that contain latex. Allograft and xenograft tissue may have been handled during processing by staff wearing gloves that may contain latex. The Food and Drug Administration (FDA) “does not believe it would be appropriate to require natural rubber labeling statements for natural rubber-free devices or foods that may be handled with latex gloves.”1 Furthermore, the “FDA is not aware of any reports of allergic reactions to rubber-free products that latex gloves have contacted.”

1Federal Register: September 30, 1997 (Volume 62, Number 189), Page 51025