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Nada Hanafi is a thought leader within the Life Sciences and MedTech industry with over 22 years of experience across the public and private sectors. She is the Founder of MedTech Strategy Advisors, LLC where she advises life-science companies on regulatory strategy, product development, and clinical research to accomplish regulatory, compliance, and business goals.
Hanafi spent over 12 years working for the Food & Drug Administration (FDA) serving in increasing roles of responsibility and ultimately, as a Senior Science Health Advisor in the Center for Devices and Radiological Health (CDRH). At CDRH, she led cross-Center and Agency programs for the advancement of the FDA's mission to promote and protect public health, including as Co-Founder of the Health of Women program, the Network of Experts program and the Patient Preference Initiative. She served as CDRH Liaison and Subject Matter Expert to the FDA’s Office of Women’s Health and the Office of Minority Health. Hanafi collaborated with the Center for Tobacco and the National Institutes of Health where she served as Senior Management Advisor to the Director at the Office of Research on Women’s Health, to improve regulatory efficiency and to strengthen data collection.
Her drive and passion to address health inequities with a focus on women and minorities led Hanafi to co-found MedTech Color, a non-profit focused on advancing the representation of people of color within MedTech.
Hanafi holds an MS in Biomaterials, a BEng in Biomedical Materials Science & Engineering from Queen Mary College, University of London, and her MPH from Johns Hopkins Bloomberg School of Public Health.
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