Specialties Planning, creating and auditing quality systems. Creating clinical plans including protocol development, case report form development, implementing and managing clinical trials. Design control to meet FDA requirements. I am a professional speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems I have over 20 years of FDA experience encompassing virtually all of the FDA field positions. I also have eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. I have personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, I was the Industry Representative on the FDA Circulatory Systems panel. Finally, I am a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. 3124-499-5148