Contact this Expert Witness
- Company: ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts
- Phone: (314) 499-5148
- Cell: (714) 473-0863
- Website: www.fdadeviceexpert.com
Specialties & Experience of this Expert Witness
General Specialties:
Medical Devices and Biomedical EngineeringKeywords/Search Terms:
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, FDA InspectionsEducation:
BA, Biological Sciences, California State University FullertonYears in Practice:
45Number of Times Deposed/Testified in Last 4 Yrs:
15Additional Information
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. Finally, a seasoned educator/speaker with over 150 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Engaged as an Expert Witness in over 40 cases. deposed 10 times and testified in court twice.