Nada Hanafi

Regulatory Affairs Lead, UCSF-STanford Pediatric Device Consortium
Medtech strategy advisors, LLC

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. Nada spent over 12 years working for the FDA, serving in increasing roles of responsibility and ultimately as a Senior Science Health Advisor in the Center for Devices and Radiological Health (CDRH), where she led cross-Center and Agency programs for the advancement of FDA's mission to promote and protect public health, including as co-founder of the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. She served as CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and the Office of Minority Health (OMH). She collaborated with the Center for Tobacco (CTP) and the National Institutes of Health (NIH) where she served as Senior Management Advisor to the Director at the Office of Research on Women’s Health (ORWH), to improve regulatory efficiency and to strengthen data collection. Nada’s drive and passion to address health inequities with a focus on women and minorities led her to co-found MedTech Color, a non-profit focused on advancing the representation of people of color within MedTech. Nada also serves on the Steering Committee and as co-lead on the Regulatory and Science Policy subcommittee for the Innovation Equity Forum (IEF) led by the NIH’s ORWH and the Bill and Melinda Gates Foundation. Nada holds an MSc in Biomaterials and a BEng in Biomedical Materials Science & Engineering from Queen Mary College, University of London. She earned her MPH from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).