Quality

Quality


RTI Surgical is committed to maintaining a robust Quality Assurance program that goes beyond effectively complying with applicable state, federal and international regulations to implement industry best practices and meet or exceed customer expectations. At RTI, quality means much more than checking a box to fulfill basic requirements. We have cultivated a culture of quality to drive continuous improvement that pervades the entire organization, with employees demonstrating a genuine commitment to quality and holding each other accountable to prioritize quality in all their actions and decisions.

Tissue & Biologics

  • 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 the following states:
    • 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)

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.

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

Medical Devices

We produce Class II and Class III medical devices using a wide range of precision manufacturing techniques and prototyping, using some of the most sophisticated equipment available today.

  • RTI is registered as a Medical Device Manufacturer with the U.S. FDA.
  • RTI’s Quality system is certified to ISO 13485:2016 Medical Devices Quality Management Systems.
  • RTI’s Quality system is certified to 21 CFR 820 Medical Devices Quality Management Systems.
  • RTI’s Quality system is MDSAP Compliant, Recommended for Certificate
  • RTI’s Quality system will be MDR complaint by Q1/2021