One Way Consultants, LLC, FDA Regulatory Experts

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

Company’s Keywords:

mock fda audits & remediation plans, designing clinical trials, training employees on all aspects of fda requirements, preparing stategic ra, qa plans for new companies, serving as an expert witness on medical devices & fda