Medical Device Approval Process: Sponsor Burdens During Regulatory Approval Process (PPT)

摘要

Founded in 1997 by Linda Braddon. Ph.D. Georgia Tech in Mechanical Engineering. Specializing in implantable medical devices. Track record of bringing medical devices to market. Co-inventor on a medical device that is CE marked in Europe and in the process of coming to the US markets. Serve as the core engineering, regulatory, and quality staff for start-up medical deveice companies.