Christina Bernstein With 20 years of business experience, including MedTech engineering, regulatory/quality and sales including the OR, Christina Bernstein is an expert in bringing new medical technologies to market in an efficient and cost-effective manner. She has extensive experience in guiding MedTech companies both in the U.S. and abroad through the FDA 510(k) approval process and down the path to profitable commercialization.
Bernstein also serves as an expert witness on legal cases that involve the failure and improper design of medical devices. In addition, she educates legal professionals on medical device risk and risk management, including what is acceptable risk, device risk management protocols, risk values assigned to identifiable hazards, and how manufacturers can reduce risk associated with their devices.
Prior to founding BB Medical Surgical in 2007, Bernstein worked in direct to consumer sales of insulin pumps and glucose monitoring systems for Medtronic Diabetes, growing the company's sales pipeline by $1.2M annually. Previously, she served on a team at the Alfred E. Mann Institute/USC tasked with bridging the gap between biomedical innovation and the creation of commercially successful medical products.
Bernstein holds a Master of Science degree in Medical Device and Diagnostic Engineering from the University of Southern California; a certificate in Engineering from the California Polytechnic University, Pomona; and a Bachelor of Science in Mathematics from Oregon State University. She has also earned her Quality Auditor certification from the American Society for Quality (ASQ) and continues her education on risk management.