REGULATORY AND QUALITY


CellRight Technologies® employs strict quality assurance and quality control procedures to ensure patient safety. Our Medical Director, a licensed physician, performs an extensive medical review of the donor medical/social history for donor eligibility. Only donors whose screening, serologic, and microbiologic tests meet or exceed current standards established by the US Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB) are accepted for processing and transplantation.

ACCREDITATION AND LICENSES

Federal Food and Drug Administration (FDA) Registration # 3009234552
American Association of Tissue Banks (AATB) Accreditation # 00212
California Tissue Bank License # CNC 80949
New York Tissue Bank License # CP173TP141TS145
Maryland Tissue Bank License # TB1898
Florida Tissue Bank License # 212

BIORINSE™ PROCESSING

All products processed by CellRight Technologies® are processed aseptically using CellRight's proprietary BioRinse™ sterilization technology, and in accordance with AATB standards and FDA federal regulations. BioRinse™ is CellRight Technologies® validated sterilization process that uses proprietary rinsing agents in multiple combinations designed to kill pathogenic microorganisms, vegetative bacteria and spores. These steps include the removal of debris, blood, bone marrow and lipids, components associated with disease transmission. The BioRinse™ process is a technologically advanced science developed by CellRight Technologies® for use in product families including CellRight Technologies® osteoinductive in-vivo verified Matrix OI®, MatrixCellect® 100 DBM putty, MatrixCellect® 100 DBM Crunch, ConCelltrate® 100, sports medicine, and conventional products. BioRinse™ in combination with our final low dose sterilization step under low-temperatures ensures a medical device sterility assurance level (SAL) of 10-6 in accordance with a Sterile "R" claim.