Humabiologics, Inc strives to meet customers research needs by providing biomaterials that produced under a quality system compliant with ISO 13485 as a provider of raw materials and components for medical devices. This is done by working with FDA-registered tissue processing facilities and regional Organ Procurement Organizations (OPOs) certified by the American Association of Tissue Banks (AATB) and compliant to 21 CFR 1271 to obtain source materials that meet all applicable industry regulations.
While Humabiologics biomaterials are not intended for transplant unless used as part of FDA submission including IND, 510(k), or PMA, Humabiologics can provide material produced under current Good Manufacturing Practices (cGMP) conditions to a specification that meets your research and investigational device/drug needs.
Please contact us with any specific questions or additional information on how Humabiologics might be able to assist your organization with their specific research needs including providing materials that comply with cGMP for clinical trials or research.
Regulatory compliance of Human-Derived Biomaterials