Healing begins with the highest standards
SAFETY AND QUALITY ASSURANCE
Tissue Recovery & Aseptic Processing
During the Tissue recovery and processing steps, every pre-caution is taken to ensure that the patient will receive safe, high quality bio-implants. Before being released, extensive donor screening and laboratory testing is performed using CLIA Certified laboratories. All Stability implants are delivered sterile to the operating room. All donor tissue recovery and processing criteria meet both FDA 21 CFR 1271 regulations and AATB Standards requirements for each HCT/P product type. Stability products are manufactured under strict controls and terminally sterilized with a validated sterilization process to ensure all products meet a SAL of 10-6.
Donor Selection & Screening
All donors must meet strict acceptance criteria as well as undergo and pass vigorous evaluation by the Medical Director. The donor’s next of- kin is interviewed and all relevant medical records are reviewed and evaluated. Each donor undergoes a rigorous screening and serological testing process to ensure patient safety.
All donor screening and eligibility criteria meet both FDA 21 CFR 1271 regulations and AATB Standards requirements for each HCT/P product type.
Licenses & Accreditations
Stability is committed to tissue safety and maintains compliance with appropriate and required regulatory agencies including the Association of American, the American Association of Tissue Banks, and the U.S. Food and Drug Administration.
Below are the frequently requested registrations, accreditations and / or licenses. Please note that documents may expire before replacements are available due to timelines inherent to the renewal process.
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MD Tissue License
Returns
Stability Biologics' mission is to provide only safe, high quality allograft tissues to health care professionals. In an effort to meet these goals, Stability Biologics will accept returned human allograft tissue provided the tissue has been consistently maintained and Stability Biologics return procedures have been followed.
No returns will be accepted that do not meet the criteria set forth in the Tissue Return and Credit Policy (click here to review). Additionally, a Return Goods Authorization (RGA) number must be issued by Stability customer service and a completed form DIST265F-02 with storage conditions attested prior to shipping a return.
To request a product return, please contact cservice@stabilitybio.com or call 855-267-5551.