Committed to Quality and Regulatory Compliance

Honoring the Gift

The gift of donated human tissue is essential for advancing scientific knowledge, developing new medical treatments, and promoting ethical and responsible research. We adhere to strict regulations and manufacture with the utmost care to show respect to the donors for their contribution to science and future lifesaving therapies.


Tissue Bank Partners

We work with FDA-registered tissue processing facilities and regional Organ Procurement Organizations (OPOs) accredited by the American Association of Tissue Banks (AATB) and compliant to 21 CFR 1271 to obtain source materials that meet all applicable industry regulations.


ISO 13485 Certified

All Humabiologics® biomaterials are produced under a quality system certified under ISO 13485 as a provider of raw materials and components for medical devices, ensuring lot-to-lot consistency and traceability throughout the manufacturing process.

View our ISO 13485 certification documentation

FDA-Registered and Inspected

We are an FDA-registered and inspected human cell and tissue establishment and remain compliant to 21 CFR 1271. By complying with FDA regulations, Humabiologics® contributes to raising the overall quality and safety standards within regenerative medicine. This benefits the industry by promoting best practices, improving patient outcomes, and fostering innovation through a more reliable and regulated environment.


Humabiologics® biomaterials are produced in compliance with current Good Manufacturing Practices (cGMP). We can develop products to a specification that meets your research and investigational device, drug, or biological product needs. Humabiologics human biomaterials are not intended for transplant unless used as part of an FDA submission including IND, 510(k), or PMA.