Nancy J. Stark, PhD

Nancy Stark, PhD, is a renowned speaker, author, and consultant in the fields of clinical research and biological safety of medical devices. Her books and seminars have benefited the career development of countless professionals, and her advice has assisted many manufacturers. In 2004, she was selected as one of 100 notable people in the medical device industry by MD&DI magazine. In 2007 she joined its Editorial Advisory Board. Dr. Stark is founder and president of Clinical Device Group (CDG) Inc., a consulting and contracting firm for medical device preapproval issues. She started the company in 1990 to provide clinical research and biological safety consulting expertise to the medical device and diagnostic industry. CDG helps clients from Europe, the United States, and Asia obtain FDA marketing clearance for their products. CDG is an industry leader in electronic training, offering a two-day webinar every month on clinical research for medical devices and two 90-minute e-conferences on advanced topics in device pre-approval issues. The Webinars are led by Dr. Stark, and the e-conferences feature guest speakers who share their expert opinions and proven strategies, how-to's, and experiences. Contributing to the industry in a variety of ways, Dr. Stark is currently cochair of the U.S. delegation (TC 194 WG 2) to ISO 14155-Clinical Investigations of Medical Devices, and serves on the U.S. delegation to ISO 10993-Biological Evaluation of Medical Devices. Dr. Stark has a BS in chemistry (Univeristy of Nebraska) and a PhD in biochemistry (University of Minnesota). She has worked in the medical device industry since 1980 at both large and small companies. She has published more than 50 articles, books, and presentations on medical device biocompatibility and clinical research. She can be reached at 773/489-5721, or at www.clinicaldevice.com.