VascuTech Medical system has been structured to assure conformity with the applicable requirements of the ISO 13485:2003 standard & the Food and Drug Administration (FDA) Quality System Regulation, 21 CFR Part 820 for medical devices.
VascuMed supports customer requirements for obtaining clearance to market medical devices by providing effective support to regulatory submissions and assuring that activities performed by VascuTech Medical conform to associated standards and regulatory requirements.
We are committed to exceeding our customer’s needs by providing the highest quality products and service, on time and within budget.
