One Way Consultants, LLC, FDA Regulatory Experts

medical devices

About

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

Technologies

NSOne Gmail Google Apps Mobile Friendly Typekit Android Node.js Remote

Keywords

preparing stategic raqa plans for new companies designing clinical trials serving as an expert witness on medical devices & fda mock fda audits & remediation plans training employees on all aspects of fda requirements medical equipment manufacturing postmarket surveillance support fda compliance training medical device validation regulatory submission support b2b clinical trial design services regulatory documentation clinical trial management medical device registration process clinical trial support regulatory consulting fda quality system regulation fda pre-submission meetings regulatory submission preparation fda labeling compliance medical device design review fda compliance audits fda software regulation fda inspection readiness fda warning letter responses medical device quality system regulation regulatory audit support

Location

833 E Rosedale Dr, East Alton, Illinois, United States, 62024-2159

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