Uncompromising Commitment to Quality and Compliance
At our company, quality and compliance are paramount. We adhere to the strictest industry standards and regulatory guidelines to ensure that every product we offer meets the highest level of safety and efficacy. Our commitment to quality control at every stage—from processing to distribution—guarantees that our clients receive only the best, reliable tissue solutions that they can trust.
Quality
Tissue Innovations upholds stringent written policies and standard operating procedures across all operations. These are regularly updated to comply with the latest standards and regulations. To maintain excellence, we conduct routine quality assurance audits on both internal and external processes, ensuring our commitment to the highest levels of quality and compliance.
Compliance
Tissue Innovations is deeply committed to upholding the highest standards of regulatory compliance in all our operations. We strictly adhere to comprehensive written policies and standard operating procedures, which are regularly updated to align with the latest industry standards and regulations.
Our rigorous quality assurance audits cover all internal and external processes, ensuring that we consistently deliver safe and reliable medical materials to our partners and the patients they serve.
Meeting and Exceeding Human Tissue Bank Standards
Tissue Innovations is accredited by the American Association of Tissue Banks and registered with the U.S. Food and Drug Administration. Additionally, we are licensed for tissue banking operations in states that require separate licensure.
American Association of Tissue Banks
The American Association of Tissue Banks (AATB) sets standards, inspects facilities, and accredits tissue banks in North America. Tissue Innovations is accredited with the AATB and is a respected member and participant.
Food and Drug Administration
The Food and Drug Administration (FDA)’s 21 CFR 1271 regulations apply to all U.S. tissue banks and their affiliates. These regulations outline criteria for tissue donor selection, and they authorize the FDA to inspect human tissue bank facilities that recover, process, or distribute tissue grafts for transplant. The FDA mandates registration and good tissue practices within the new regulations. Tissue Innovations is registered with the FDA and is in full compliance with their regulations.
Licensing &
Certification
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