The Nanofiber Solutions product is a synthetic, fully resorbable vascular graft that is custom made according to the patient’s anatomy. This device could drastically enhance the treatments available for children suffering from congenital heart disease (CHD). NCC-PDI provided continued support for the completion of additional rat implantations and completion of second quality audit to move towards GMP manufacturing of medical devices. NCC-PDI also helped with submission of a manuscript for publication. Submitted direct to Phase II SBIR for tissue-engineered vascular graft technology applied to AV grafts. NCC-PDI helped acquire quality audit to achieve ISO 13485 certification for manufacturing of medical devices.