The US BioDesign Quality Management System has been ISO 13485:2003 certified since February 19, 2013. The scope of our certification specifically includes: “Custom Engineering and Manufacturing of Biomedical Textile Components for Medical Device Manufacturers, Including the Cardiovascular, Orthopedic, General Surgery and Neurological Device Markets”. Original certification and ongoing maintenance audits are performed yearly by TÜV SÜD America Inc.
All manufacturing occurs within a clean, controlled environment and personnel wear protective clothing to keep the work environment free from contamination.
Quality excellence is the foundation of our manufacturing organization. Our standard operating procedures, document control, equipment maintenance and employee training ensure that the implantable fabrics we produce will conform to your specifications.
US BioDesign is ISO 13485:2003 Certified
To view or download our ISO certificate, please click here.