Nada Hanafi

SVP- Regulatory Strategy, Veranex
 

MedTech Color Co-Founder & Board Treasurer

Collaborative Community Executive Planning Committee

Nada joined Experien Group in 2017 after working 12 years at FDA’s Center for Devices and Radiological Health (CDRH). Since 2010, she had been a CDRH Senior Science Health Advisor, serving as an expert consultant and senior advisor in the Center Director’s office. Nada combines her deep institutional knowledge with innovative approaches to help companies successfully communicate product information to FDA throughout the total product life cycle. Leveraging her years of reviewer experience and broad FDA exposure, she develops actionable premarket strategies to guide programs through successful submission. She also orchestrates compliance activity. While at FDA, Nada led postmarket investigations for ob-gyn devices, wrinkle fillers, tanning devices, breast implants, negative pressure wound therapy (NPWT) devices and metal-on-metal hip implants and she applies this knowledge to help companies effectively manage postmarket requirements. At Experien Group, Nada helps medical device and combination product manufacturers generate regulatory/clinical roadmaps for success. Building upon her strong engineering background, she helps companies devise and position product performance testing and/or clinical studies to achieve major milestones. Nada holds an MS in Biomaterials and a BE 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).