Rac Kevin E. Daly is a seasoned regulatory, clinical, and quality leader with 30+ years of experience in the medical device and drug/device combination product industries. He has contributed to FDA Class II and III products in various executive and individual capacities across the medical device and pharmaceutical sectors. His areas of specialization include regulatory compliance, clinical affairs, quality management systems, medical devices, combination products, and post-market surveillance. Daly has experience with FDA filings like PMA, IDE, 510(k), PIND, IND, and CDER, as well as European regulatory requirements like EU MDD/MDR, CE Marking, and ISO 13485.

Kevin Daly studied BS at Fairleigh Dickinson University-Metropolitan Campus and took post-graduate business courses at Rivier University and Stevens Institute of Technology.

He has held executive roles such as Co-Founder, President, and COO at CXL Ophthalmics, Vice President of Regulatory Affairs, and Quality Assurance at MicroVention Terumo, Vice President of Regulatory/Clinical/Quality at MicroTherapeutics, Director of Regulatory and Clinical Affairs at Medtronic Intervascular Vascular, Director of Regulatory Affairs and Compliance Standards at InterVentional Technologies, and Quality Assurance Supervisor at Meadox Medicals. Additionally, Daly has served as a Principal at a self-owned regulatory/clinical consulting firm.

Kevin Daly's experience has allowed him to develop expertise and skills in FDA regulations, international regulatory requirements, clinical trials, quality management systems, medical device compliance, premarket submission, post-market surveillance, and combination product development.