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
- California State University, Fullerton, Bachelor of Arts, 1970. Biological Sciences Golden Gate University, Santa Barbara, CA, MBA Program: One year Completed; 1982-83
- FDA Commendable Service Award, 1974 FDA Special Achievement Award, FDA Office of Criminal Investigations, 2009
- “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
- Curriculum Vitae.
The complete resume of J. Lawrence Stevens
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).