Fda Compliance Expert Witnesses

Los Angeles, California

Products Liability, Manufacturing - Product Liability, Supply Chain, Manufacturing Defect, Product Defect, Product Recall, Mass Tort, Class Action, Quality Assurance, Labelling, Product Safety, Causation, Standard of Care, Supply Chain Disruption, Third-Party Logistics, Distribution, FDA Compliance, California Proposition 65, Inventory Loss, Warehousing, CPSC Compliance

Dr. Phiroz is a nationally recognized expert witness specializing in product liability, manufacturing defects, and supply chain failures. He provides expert testimony in cases ranging from individual product defect claims to mass tort and class action litigation, representing both plaintiffs and defendants in matters involving product recalls, quality assurance failures, supply chain disruption, causation analysis, and regulatory compliance. At Procter & Gamble (NYSE:PG), Dr. Phiroz held senior leadership roles driving transformative supply chain initiatives overseeing demand forecasting, supply chain infrastructure, and recall analysis. He currently holds faculty positions at Harvard University and Michigan State University, teaching undergrad/grad courses in supply chain and operations management. In 2023, he was appointed as a Fellow at Harvard University (Inclusive Practice Fellowship). As a retained testifying expert, Dr. Phiroz has provided expert testimony in federal and s...

East Alton, Illinois

Medical Devices, Biomedical Engineering - 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. Finally, a ...

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 ...

New York City , New York

Medical Devices, Pharmaceutical Regulation - Medical Device FDA Regulation, Biologics FDA Regulation, FDA Compliance, FDA Warning & Labels, Product Liability, FDA Regulations, Medical Device Product Liability, Clinical Trials FDA Regulation, Medical Device FDA Approvals-Clearance, Medical Device Recalls, Medical Device Complaints, Biomedical Engineering

Dr. Ediuska Laurens is a highly credentialed biomedical engineer and expert in FDA regulation, compliance, and product liability for medical devices and biologics. She provides expert witness services to both plaintiff and defense counsel in litigation involving medical device and biologics FDA approval and clearance, labeling and warnings, quality systems, adverse event reporting, clinical trials, and post-market surveillance. Dr. Laurens brings over 20 years of combined industry, research, and regulatory experience. She has led regulatory and quality efforts across the entire medical device lifecycle, from concept through commercialization, supporting product development, regulatory submissions, and quality compliance for a wide range of technologies, including cranial and orthopedic implants, spinal and neural devices, tissue engineered-biologics and combination products, hydrogel biomaterials, as well as pediatric and women’s health innovations, among others. Attorneys rely on...

Saint-Augustin-de-Desmaures, Quebec

Biomedical Engineering, Electrical Engineering - Medical device failure, Neuromodulation, Power electronics, Design defect, Olympus, FDA compliance, Electronics failure, Instrumentation, Failure forensics, Boston Scientific, Patent infringement, Biomedical patents, Regulatory analysis, Medical instrumentation, Implantable devices, Space electronics, Product recalls, Device safety

Eric A. Bharucha is a multidisciplinary systems engineer with 25+ years solving complex technical challenges across biomedical, aerospace, and industrial sectors. Currently completing PhD in Electrical Engineering (ABD) with expertise spanning electronics, biology, physics, and systems integration. TECHNICAL EXPERTISE: - Medical device design, safety, and regulatory compliance (FDA/CE) - Neuromodulation systems and implantable devices (Boston Scientific, St. Jude) - Electronic system failure analysis and forensic investigation - Silicon photonics and advanced sensor systems - Aerospace electronics and environmental testing - Manufacturing quality control and process analysis - Patent analysis and intellectual property disputes COMMERCIAL EXPERIENCE: - Led design teams for commercial medical devices (Olympus, Boston Scientific) - Developed products from research prototype to manufacturing transfer - Resolved critical failures saving clients $75M+ in offshore robotics - Expert in re...