All designs have gone through a rigorous product development cycle, including a battery of tests to help assure reliable performance. As an FDA registered, ISO 13485:2003 Quality Certified Company, we not only manufacture in accordance with the most stringent Food and Drug Administration (FDA) requirements, we raise the quality paradigm to a new level by strictly controlling the manufacturing environment through highly automated and sophisticated processes. These measures help to assure that our products perform to unsurpassed quality levels – each and every time.