Diana Williamson is a Principal Consultant at CardioMed Device Consultants with extensive experience in medical device development, design controls, and regulatory compliance. A former Vice President of Research and Development, she helps manufacturers navigate complex engineering challenges, implement effective quality systems, and advance Class II and Class III devices from concept through commercialization. Her expertise includes cardiovascular and neurovascular technologies, verification and validation, and FDA and international regulatory requirements.
Experience
Prior to joining CardioMed in 2023, Ms. Williamson served as Vice President of Research and Development at Svelte Medical Systems, where she led coronary stent development from inception through commercialization, including FDA PMA approval of the SLENDER IDS® and DIRECT RX® systems. She directed multidisciplinary engineering teams, device testing programs, and design control processes supporting regulatory approvals in the United States, Europe, and Japan.
Previously, Ms. Williamson held engineering positions at Cordis (Johnson & Johnson) and Concentric Medical (now Stryker), focusing on coronary, peripheral vascular, and neurovascular devices. She began her career in research and development at Guidant Corporation (now Abbott Vascular).
At CardioMed, Ms. Williamson advises manufacturers on product development, design controls, verification and validation, quality management systems, and compliance with FDA requirements, ISO 13485, and the European Medical Device Regulation (EU MDR). She is an inventor on seven issued U.S. patents.