Nancy J Stark PhD, Biosketch
Nancy in Milan

Nancy J Stark is a renowned speaker, author, and consultant in the fields of clinical trials 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. Since 2003 she served as US Co-chair to the ISO 14155 committee.

Whitepapers & Blogs
Dr. Stark regularly publishes whitepapers and blogs about medical device approval issues. You may sign up to receive the whitepapers by email or catch up on your reading at the Whitepaper Blog

FDA Consulting and 'CRO-ing'
Recognizing medical device manufacturers' need for access to consultants and clinical contracting services specializing in medical devices, Dr. Stark founded Clinical Device Group Inc in 1990. The company provides regulatory, clinical trial, clinical evaluation, and biological safety consulting to the medical device and diagnostic industry. CDG helps clients from the United States, Europe, and Asia obtain FDA marketing clearance for their products.

Dr. Stark is an industry leader in training. She offers half-day sessions (Workshops) on the fundamentals of device investigations and regulations. These courses are designed and presented personally by Dr. Stark, draw on her many experiences in the industry, and are available pre-recorded on CD. Custom and/or live webcast training is also available.

Other Industry Contributions
Always looking for ways to contribute to the industry, Dr. Stark currently serves on the US delegation to ISO 10993 - Biological Evaluation of Medical Devices.

Nancy J. Stark has a BS in chemistry (University of Nebraska) and a PhD in biochemistry (University of Minnesota). She has worked in the medical device industry since 1980 at both large companies (3M Company) and small (Hollister Incorporated.) She has published more than fifty articles, books, and presentations on medical device biocompatibility and clinical research. You can obtain her CV here

Dr Nancy J Stark can be reached at 1-773-489-5706, or at

CDG Contact Information