Christian Svejk

Director of Quality

Since graduating from Vanderbilt University, Christian has nearly 30 years of experience in a variety of positions in medical device companies, spanning the areas of manufacturing, quality assurance, ISO, cGMP, MDD/MDR, and MDSAP compliance, and product design. Much of his previous job experiences have been in a product design capacity, which required the management of multiple projects simultaneously and field studies of new products. Christian’s experience has included FDA Class 1, Class 2, & Class 3 GMP regulated devices including medical fiber optics, catheters associated with electrophysiological applications, implantable orthopedics, active implants, dental systems, ultrasound systems, and mammography systems. He has successfully managed six FDA Inspections and two MDSAP audits and has been the Management Representative that acts as the primary contact with the regulatory authorities.