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Expert Profile
Larry Stevens
Principal Consultant, One Way Consultants LLC
Larry is a professional speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has 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, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is 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.
Trainings by Expert
Effective (FDA Accepted) Responses to FDA-483's and Warning Letters
Category:
All FDA Regulated Industry
Effective (and FDA Compliant) Management Reviews
Category:
All FDA Regulated Industry
The Mindset of an FDA Employee
Category:
All FDA Regulated Industry
Conducting Successful FDA Meetings
Category:
All FDA Regulated Industry