Nancy J. Stark, Ph.D., 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, her advice has assisted many manufacturers. In 2004, she was selected as one of 100 notable people in the medical device industry by Medical Device & Diagnostic Industry magazine. In 2007 she joined their Editorial Advisory Board.

FDA Consulting

Dr. Stark is founder and President of Clinical Device Group Inc., a consulting and contracting firm for medical device pre-approval 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.

Workshop and e-Conference Training

Clinical Device Group is an industry leader in electronic training, offering half-day  workshops on clinical research for medical devices and  90-minute e-Conferences on advanced topics in device pre-approval issues. The workshops are led by Dr. Stark, the e-Conferences feature guest speakers who share their expert opinions and proven strategies, how-to's, and experiences. Both workshops and e-Conferences are rich content events.

Other Contributions

Contributing to the industry in a variety of ways, Nancy J. Stark is currently co-chair of the US delegation (TC 194 WG 2) to ISO 14155 - Clinical Investigations of Medical Devices, and serves on the US delegation to ISO 10993 - Biological Evaluation of Medical Devices. Clinical Device Group hosts the Clinical Device Forum, an international, online discussion forum for device pre-approval issues.

Background

Nancy J. Stark has a BS in chemistry (U of Nebraska) and a PhD in biochemistry (U of Minnesota). She has worked in the medical device industry since 1980 at both large companies and small. She has published more than fifty articles, books, and presentations on medical device biocompatibility and clinical research. You can obtain her CV here Download CV.

Dr. Nancy J. Stark can be reached at 1-773-489-5721, or at www.clinicaldevice.com