Fda Regulatory Expert Witnesses

STEVENSVILLE, Maryland

Pharmaceutical Regulation, Medical Devices - FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times. Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries. Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it? Provide FDA related ...

Orford, New Hampshire

Medical Devices, Biomedical Engineering - Failure Analysis, Design History File (DHF), FDA Regulatory, Orthopedic Implants, Hip Implants, Knee Implants, Cardiovascular, Neurological Devices, Urological, Surgical Tools, Surgical Mesh, Warming Systems, EEG, Biosensors, Biomaterials, Polymers, Metals, ISO Standards, Patent Litigation, Rehab Devices

Dr. Jay Vincelli, PhD, PE, is a licensed Professional Engineer (PE) in mechanical engineering and a PhD-level biomedical engineer specializing in the forensic analysis and development of medical devices for manufacturers, product liability, and patent litigation matters. Litigation Support & Forensic Leadership Dr. Vincelli has directed the technical investigation and forensic strategy for over 110 medical device matters. As a former Laboratory Director, he managed the protocol development and testing for complex litigation involving orthopedic implants, surgical mesh, IVC filters, forced-air warming systems, and many other devices. He combines this high-volume experience with deep technical rigor, notably conducting a large-scale retrieval study at Dartmouth College involving the failure analysis of over 500 metal-on-metal hip implants. Dr. Vincelli has served as the designated expert witness in multiple depositions, including the Christiansen v. Wright bellwether trial. Regulat...