Carrie Kuehn, PhD
principal clinical consultant
Dr. Carrie Kuehn is a talented medical device regulatory and clinical affairs professional with a diverse background and over 25 years of experience in research epidemiology, medical devices, regulatory and clinical affairs, and patient-focused policy. In practice, Dr. Kuehn applies her expertise, leadership, strategic remediation skills, and broad medical device clinical-regulatory knowledge to address the needs of medical products companies and stakeholders across therapeutic areas. Dr. Kuehn excels at taking complex, multidisciplinary problems and synthesizing them into a cohesive strategy. She is particularly skilled at stepping into crises, supporting remediation efforts, conducting gap analyses, reorienting strategic plans, and bringing positive results out of fire-drill situations.
Carrie has worked as a regulatory affairs consultant for the medical device industry supporting pre-market submission activities (510(k), PMA, IDE and Q-sub engagements) and post-market clinical, regulatory, and compliance activities. Carrie has diverse industry experience in various therapeutic areas and particular expertise in cardiovascular, orthopedic, SaMD, and digital health medical device sectors. Carrie has successfully navigated complex responses to regulatory authorities in the U.S., EU, and Australia. She has a deep understanding of the clinical data necessary for AI/ML medical devices, requirements for validation and controls of bias, diversity and generalizability of data supporting AI/ML algorithms. Carrie has experience with FDA regulation of Class II, Class III, SaMD, Clinical Decision Software, and AI/ML medical devices. Carrie has led global multi-site post-market clinical research teams responsible for generating clinical evidence to support EU MDR submission and approval, and successfully reduced and closed questions in rounds of review under EU MDR. Carrie has remediated quality systems, QMS documentation, CAPAs, PMS systems and data, and 483 findings. She has also successfully communicated data to reduce recall classification, overhauled regulatory and clinical processes and procedures, and successfully implemented system improvements to ensure medical device clearance and approval in the U.S., EU, and beyond.
For more information, please see her LinkedIn Profile.