Sharon Kvistad is an Associate Director in Guidehouse's Healthcare and Life Sciences Disputes, Regulatory, Compliance, and Investigations practice, focusing on FDA regulatory matters.
Sharon has over 30 years of experience in U.S. and global regulatory affairs as they relate to medical devices. She is expert at guiding both established and start-up companies through FDA regulatory processes, the development and execution of regulatory strategies, and preparation of clinical and marketing applications to government bodies. Her domestic submission preparation experience includes IDE, PMA, PMA/S, HUD/HDE, and 510(k). In addition, she serves as the regulatory member on product development teams and interfaces with FDA and other government agencies on behalf of clients.
Sharon has deep experience with procedure development and implementation, staff training program administration, and regulatory training to engineering, manufacturing, marketing and sales departments. Her product experience includes interventional cardiology products, short- and long-term cardiac implantables and accessories, vascular access catheters, cochlear implants, and Class I products.