Fda Medical Device Regulation Expert Witnesses
Fda medical device regulation expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on fda medical device regulation. The fda medical device regulation expert witness listings on this page are typically from fields/areas of expertise such as: Biomedical Engineering and Medical Devices.
J. Lawrence Stevens, RAC
FDA Medical Device Expert
ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts
East Alton, Illinois
Medical Devices, Biomedical Engineering
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FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints
A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling.
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. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices.
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