Improving patient lives by providing expertise in clinical and regulatory affairs, patient engagement, and advocacy for patient-centric regulatory policy.
I am a talented medical device regulatory and clinical affairs professional with a diverse background and over 25 years of experience in epidemiology, medical devices, regulatory and clinical affairs, and patient-focused policy. I apply my expertise, leadership, strategic remediation skills, and broad medical device regulatory knowledge to address complex issues in the pre-market and post-market space to enhance compliance, fine tune business practice, and improve patient lives around the world. With the increase in clinical requirements being imposed on medical device companies globally, I can provide critical expertise in observational and clinical research methods, execution, and publication of clinical results to achieve and maintain market authorization.
I am valued for my ability to simplify complex, multidisciplinary problems into a cohesive strategy that leads to efficient solutions. I am an accomplished researcher with exceptional written communication skills, having published in the areas of public health, regulatory affairs, and patient-focused policy. I excel at written and verbal communications with regulatory authorities, and I am an expert at navigating regulatory policy, particularly for medical device and software as a medical device (SaMD) products.
I am available to provide clinical and regulatory affairs consulting, policy research and advocacy support, and patient engagement strategy development. Ad hoc, short-term, and long-term consulting arrangements are available.
Contact me to determine how I can best apply my adaptable skill set to address the complex issues you may be facing in your efforts to improve patient lives around the world.
You can find a copy of my curriculum vitae here. I look forward hearing from you!
Evergreen Strategic Consulting, LLC is proud to be recognized by the following certifications and chamber of commerce memberships.
Certified LBGT Business Enterprise (Certified LGBTBE) by the National LGBT Chamber of Commerce
Dr. Carrie M. Kuehn, Principal Consultant & Founder
Credentials
Doctor of Law and Policy
Dissertation: Role of Patient Advocacy Stakeholders in Science‐based Regulatory Policy at the U.S. Food and Drug Administration (FDA). Boston, MA, Northeastern University, College of Professional Studies
Regulatory Affairs Certified (RAC), U.S. Medical Device and Pharmaceutical Regulatory Affairs (2011-2023)
Certificate in U.S. Pharmaceutical & Medical Device Regulatory Affairs. Rockville, MD. Regulatory Affairs Professional Society (RAPS)
Master of Public Health, Epidemiology
Thesis: Birth Malformations and Residential Proximity to Hazardous Waste Sites in Washington State. Seattle, WA, University of Washington, School of Public Health
Master of Arts, Biocultural Anthropology
Thesis: Dermatoglyphic Asymmetry and Handedness in Individuals Exposed to Alcohol Prenatally. Seattle, WA, University of Washington, Department of Anthropology
Bachelor of Arts, Anthropology
Seattle, WA, University of Washington, Department of Anthropology
Selected Publications
Kuehn, CM. A Proposed Framework for Patient-Focused Policy at the U.S. Food and Drug Administration. Biomedicines. 7(64). August 27, 2019.
Marsh K, Hawkin N, Brookes E, Kuehn C, Liden B. Patient-centered benefit-risk analysis of transcatheter aortic valve replacement. F1000Research. 8(394. May 20, 2019
Kuehn, CM and Selig, WKD. Literature Review: Patient Engagement in Clinical Trials. A Report of the Science of Patient Input Program of the Medical Device Innovation Consortium (MDIC). March 29, 2019.
Kuehn, CM. Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making: A Policy Process Perspective. Therapeutic Innovation and Regulatory Science. Sep 2018; 52(5): 661 – 668.
Kuehn, CM, Bockmuller, T. Considerations for Discovery in Medical Device Litigation. Rx for the Defense. DRI Newsletter of the Drug and Medical Device Committee 2015: 23(4). 6‐8.
Glezen WP, Schmier JK, Kuehn CM, Ryan KJ, Oxford J. The burden of Influenza B: A structured literature review. American Journal of Public Health March 2013; 103(3): e43‐e51.
Yorkston KM, Kuehn CM, Johnson KL, Ehde DM, Jensen MP, Amtmann D. Measuring participation in multiple sclerosis: A comparison of the domains of frequency, importance, and self‐efficacy. Disab Rehab 2008; 30(2):88‐97.
Cetin K, Johnson KL, Ehde DM, Kuehn CM, Amtmann D, Kraft GH. Antidepressant use in multiple sclerosis: Epidemiologic study of a large community sample. Multiple Sclerosis 2007; 13(8):1046‐1053.
Jensen MP, Kuehn CM, Amtmann D, Cardenas DD. Symptom burden in persons with spinal cord injury. Arch Phys Med Rehab 2007; 88(5):638‐645.
Johnson KL, Dudgeon B, Kuehn CM, Walker W. Assistive technology use among adolescents and young adults with spina bifida. Am J Pub Health 2007; 97(2):330‐336.
Kuehn CM, Mueller BA, Checkoway H, Swanson M. Risk of malformations associated with residential proximity to hazardous waste sites in Washington State. Environ Res 2007; 103(3):405‐412.
Mueller BA, Kuehn CM, Shapiro‐Mendoza CK, Tomashek KM. Fetal deaths and proximity to hazardous waste sites in Washington State. Environ Health Perspect 2007; 115(5):776‐780.
Johnson KL, Kuehn CM, Yorkston KM, Kraft GH, Klasner E, Amtmann D. Patient perspectives on disease‐ modifying therapy in multiple sclerosis. Int J MS Care 2006; 8(1):11‐18.
Podvin D, Kuehn CM, Mueller BA, Williams M. Maternal and birth characteristics in relation to childhood leukemia. Paediatric Perinatal Epidemiol 2006; 20(4):312‐322.
Johnson KL, Amtmann D, Yorkston KM, Klasner ER, Kuehn CM. Medical, psychological, social and programmatic barriers to employment for people with multiple sclerosis: A review of the literature. J Rehab 2004; 70.
Johnson KL, Yorkston KM, Klasner ER, Kuehn CM, Amtmann D. The cost and benefits of employment: A qualitative study of experiences in individuals with multiple sclerosis. Arch Phys Med Rehab 2004; 85:201‐209.
Yorkston KM, Johnson KL, Klasner ER, Amtmann D, Kuehn CM. Getting the work done: A qualitative study of individuals with multiple sclerosis. Disab Rehab 2003; 25(8):3690‐379.
Book Chapters
Ochoa JA, Siskey R, Kuehn CM, Ciccarelli L. Medical device regulation and retrieval analysis. In: Beyond the Implant: Retrieval Analysis Methods for Implant Surveillance. Ed. William M. Mihalko, Jack Lemons, Seth Greenwald, and Steven M Kurtz. 2018.
Kuehn CM. and Yardimci A. Best Practices for Documenting Objective Evidence of Verification & Validation. In: The Medical Device Validation Handbook. Ed. Roberta Goode. 2018
Kuehn CM, Jennings J. Chapter 7. Current good manufacturing practices & quality system design. In: US Fundamentals of Regulatory Affairs, Tenth Edition, 2017.
Kuehn CM, Jennings J. Chapter 10. Current good manufacturing practices & quality system design. In: US Fundamentals of Regulatory Affairs, Ninth Edition, 2015.
Kuehn CM, Siskey R. Good manufacturing and laboratory practice for medical device development (cGMP and cGLP). Ch. 3‐9. In: Bringing Your Medical Device to Market, 3rd Edition. Reiss JB (ed), FDLI, 2013.
Weiler (Kuehn) CM, Taylor KM. Forensic anthropology. pp. 179‐189. In: Forensic Medicine Sourcebook. Muth AS (ed.), Omnigraphics, Detroit, MI 1999.