Dr. Cynthia Nolte PhD, RAC

Medical Device Consultants, Inc

Cindy has fifteen years of experience in medical device regulatory affairs, with varied expertise including the regulation of infection control products, stand-alone software products, software-controlled instrumentation, implantable devices, and tissue engineered products. In recent years, Cindy has become increasingly involved in a number of important, long-term projects in the field of diabetes management including insulin delivery devices, blood glucose monitoring technologies, and stand-alone software products for blood glucose control. She has participated in a number of pre-IDE meetings with FDA and authored 510(k) premarket notifications for a range of complex medical device products and systems. Prior to joining MDCI in 1995, she was a staff scientist at Organogenesis, Inc., where she was involved in the design and development of cellular tissue substitutes. Cindy is a member of the Regulatory Affairs Professionals Society, the Association for the Advancement of Medical Instrumentation, and the North Carolina Regulatory Affairs Forum. She holds a B.A. in biology from Wheaton College and a Ph.D. in biochemistry from Boston University. She is Regulatory Affairs Certified.


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