One Way Consultants, LLC FDA Regulatory Experts

One Way Consultants, LLC FDA Regulatory Experts

J. Lawrence Stevens, RAC

833 E. Rosedale Dr. East Alton, IL 62024

About the Expert

Serve as an expert witness for cases involving FDA regulation compliance for medical devices. including product submissions, quality systems and clinical trials compliance. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical regulatory and quality in the medical device industry. Personally managed 7 clinical trials of medical devices Performed BioResearch Monitoring inspections while at FDA.

Areas of Expertise

  • Medical Devices
  • Medical Research / Clinical Trials

Expert's Profile

Serve as an expert witness for cases involving FDA regulation compliance for medical devices.
Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. 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, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, 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. www.fdadeviceexpert.com

Personal Achievements

Education

  • California State University, Fullerton, Bachelor of Arts, 1970. Biological Sciences Golden Gate University, Santa Barbara, CA, MBA Program: One year Completed; 1982-83

Honors

  • FDA Commendable Service Award, 1974 FDA Special Achievement Award, FDA Office of Criminal Investigations, 2009

Publications

  • “What to Expect When You Are Inspected “ Endovascular Today Magazine, January 2004 "Design Verification" Medical Devices and Diagnostics Industry. Vol. 16, No. 1, January, 1994 "Practical Aspects of the Clinical Evaluation of a Medical Device", Medical Devices and Diagnostics Industry. Vol. 7, No. 4, April, 1985

More Information

Listed in the Following States

One Way Consultants, LLC FDA Regulatory Experts is listed with ExpertPages in the following jurisdictions: All US Regions and States, Canada (all Provinces).