Carrie Kuehn FDA

Carrie Kuehn

FDA Reg Affairs Expert

Dr. Kuehn is Regulatory Affairs Certified (RAC) and specializes in U.S. FDA medical device regulatory affairs, Quality System Regulations (QSRs), design control, regulatory strategy, and regulatory compliance.

Dr. Kuehn is an expert in new FDA regulatory policies focused on the use of patient preference (or patient experience) data in regulatory decision-making. At Exponent, Dr. Kuehn provides consulting expertise in medical device FDA regulatory affairs, which includes in depth review of regulatory documentation to support various types of litigation; strategic and technical support for pre- and post-market medical device safety issues, regulatory pathway determination, and FDA submissions; independent review of documentation related to field actions, response to FDA inquiries, and other compliance activities; analysis of post-market medical device surveillance data; and insights related to evolving FDA regulatory policy.

An epidemiologist by training, Dr. Kuehn brings more than 20 years of diverse training and experience to meet the needs of both legal and medical device industry clients.