FDA Expert Witness Listings

Welcome to our FDA experts directory. Browse the profiles below to find the right expert witness in FDA for your case. Our SEAK Expert Witness Database is always free to search.

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Christopher M Daft, PhD River Sonic Solutions, LLC

San Francisco, California
Intellectual Property Expert Witness, Medical Devices Expert Witness - Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, DFSS, Regulatory, Integrated Circuit, Semiconductors, Biometric security, Ablation, Tomography, Parallel Computing, Minimally Invasive Surgical Guidance, Wearable Medical Device, Product Liability
Award winning, Oxford Educated scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing and image processing. Dr Daft has deposition and trial testimony experience. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 25 U.S. Patents with several pending. Completed more than 84 hours of SEAK Expert Witness Seminars, including patent-specific training. Diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung and Siemens as well as several start-ups. Well published. Winner of grants from National Institute of Health. Extensive international consulting experience. IEEE (Institute of Electrical and Electronic Engineers) Senior Member since 2004. Three years’ experience teaching electrical and computer engineering at the University of Illinois. Holds BA and MA in Physi...
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John B. Slate, PhD Slate Engineering

Encinitas, California
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Medical Instrumentation, Product Development, Safety, Risk Management, Patents, FDA, Quality Systems, Infusion Pumps, Injection Devices, Dry Eye Treatment Devices, Embedded Control Systems, Sensors
Over 35 years of experience developing medical devices for use in hospitals, clinics, and home care. Dr Slate has held senior management positions leading teams from product conception through manufacturing including conducting clinical studies, obtaining safety certifications, and preparing FDA submissions. A technical contributor skilled in the design of electromechanical systems and embedded controllers, he is an inventor on 24 issued U.S. patents, which are primarily in the field of infusion pumps and injectors for self-administration of insulin and other medications stored in prefilled containers. Experienced in complying with FDA regulations for Quality Management Systems including design control activities such as documenting product requirements, developing the risk management file, and conducting product verification and validation testing.
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Tom Wilson, MSME TGWilson Consulting LLC

Guilford, Connecticut
Biomedical Engineering Expert Witness, Medical Devices Expert Witness - Orthopedics, Allograft, Spine, Biomechanics, Failure Analysis, Testing, Clinical Studies, Design Controls, FDA, ISO, Manufacturing, Intellectual Property
Tom is an engineering professional with 30 years of experience in the medical device industry with a focus in orthopedics. Legal services include consulting, analysis and expert witness support in product lability and intellectual property matters. He has held engineering and leadership positions in hip, knee, spine, allograft and craniomaxillofacial sectors in start-up to large size companies with direct involvement in all facets of business from concept to commercialization. He served as Vice President of Research & Development at a spinal device start-up where he and his team grew the portfolio into a full-line offering. Tom founded TGWilson Consulting LLC in 2019 to provide engineering, business development and legal services to the industry. He has extensive field experience with surgeons, OR staff and sales personnel making technical calls and covering surgical cases. Tom also has clinical study experience in the US and abroad including study design, regulatory submissions, en...
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Joshua Sharlin, PhD Sharlin Consulting

Washington, District Of Columbia
Pharmaceutical Regulation Expert Witness, Medical Devices Expert Witness - FDA, FDA expert FDA Compliance, FDA Regulations, FDA MAUDE , FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device expert, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability
Dr. Sharlin’s experience: (1) Drug reviewer at FDA. (2) 25 years of experience providing compliance support to FDA-regulated companies. (3) 10 years of experience as an expert witness. Over 30 cases. (4) Cases involving drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance. (5) Authority in software development and data integrity. (6) Expert at explaining FDA compliance – over 50,000 people paid to attend my 45 different classes. Dr. Sharlin’s benefits: (1) Succeed in depositions. (2) Identify documents for discovery. (3) Develop questions for witnesses. (4) Find the opposition’s vulnerabilities. (5) Develop arguments and identify facts that supports a legal strategy. (6) Write convincing expert reports.
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Catherine E Patterson, PhD Biotech Research Group (BRG)

Tampa, Florida
Pharmaceutical Regulation Expert Witness, Warnings & Labels Expert Witness - Pharmaceutical, Drug, Device, Failure to Warn, Labeling, FDA, Regulatory, Product Liability, OTC, Prescription, Safety, Risk
Dr. Patterson has focused on human disease and treatments with attention to both efficacy and safety. Investigations of medical literature, legal files and regulatory documents for medical conditions, drug products and medical devices as well as comparators are the basis of her regulatory opinions. Any pharmacovigilance, device safety reviews, adverse event and labeling analyses use resources such as PubMED, Embase, FAERS, MAUDE, and internal company documents. Her regulatory experience has included 510(k), PMA, pre-IND, IND, NDA, ANDA and 505(b)(2) submissions. Dr. Patterson routinely writes FDA submissions, white papers, clinical study protocols, medical descriptions and labeling. She has additional experience with peer-review publications and grant writing. She is currently the Chief Scientific Officer for Biotech Research Group in Tampa. Her PhD was awarded from Princeton University in Molecular Biology for her work with viruses. In the past she provided scientific re...
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J. Lawrence Stevens, RAC ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts

East Alton, Illinois
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - 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 Inspections
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 ...
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Ann Prewett, PhD

Bloomfield, Michigan
Medical Devices Expert Witness, Products Liability Expert Witness - medical device, implant, bone graft, orthopedic, vascular grafts, collagen, biomaterials, hydrogels, FMEA, FDA, CE Mark, Design Control, ISO13485: CAPA, biocompatibility testing, spine, spine fusion, chemical analysis, chemical characterization, sterilization, ethylene oxide, wear debris, 510k
Medical device expert with PhD in Chemistry and 28 years experience. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial for product liability and patent cases. Authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Have worked in all areas of product development from conception, design, design validation, design transfer, production and commercialization. Responsibilities included preclinical safety, chemical analysis, residual testing, biocompatibility ISO 10993, static/ fatigue biomechanical testing. Invented and commercialized an FDA, 510k cleared product. Invented and launched minimally invasive spine products sold in Europe under CE Mark. Wrote Clinical Evaluation Reports and biological safety for EU MDR 2017/745. Recer...
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Ann Prewett, PhD

New Jersey
Medical Devices Expert Witness, Products Liability Expert Witness - medical device, implant, bone graft, orthopedic, vascular grafts, collagen, biomaterials, hydrogels, FMEA, FDA, CE Mark, Design Control, ISO13485: CAPA, biocompatibility testing, spine, spine fusion, chemical analysis, chemical characterization, sterilization, ethylene oxide, wear debris, 510k
Medical device expert with PhD in Chemistry and 28 years experience. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial for product liability and patent cases. Authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Have worked in all areas of product development from conception, design, design validation, design transfer, production and commercialization. Responsibilities included preclinical safety, chemical analysis, residual testing, biocompatibility ISO 10993, static/ fatigue biomechanical testing. Invented and commercialized an FDA, 510k cleared product. Invented and launched minimally invasive spine products sold in Europe under CE Mark. Wrote Clinical Evaluation Reports and biological safety for EU MDR 2017/745. Recer...
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Nancy J. Chew, M.S., RAC, FRAPS Regulatory Affairs, North America, Inc.

Durham, North Carolina
Pharmaceutical Regulation Expert Witness - FDA, Food and Drug Administration, 21 U.S.C. and 21 CFR, Investigational New Drug Applications, New Drug Applications, FDA-regulated product development and registration, regulatory affairs practice, FDA regulated industry, submissions/dossiers, labeling, compliance.
Specialty Focus: FDA regulatory requirements, Product development strategy, FDA-regulated product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (CTDs, NDAs), FDA approvals, US agent for FDA matters. Education: M.S. Physiology, Florida State University, 1968. B.A. Biology, Woman's College of the University of North Carolina, 1963. Years in Practice: 35+ Additional Information  Certified regulatory affairs expert with over 35 years experience in pharmaceutical regulatory affairs.  Significant teaching experience in the pharmaceutical and regulatory field, and lectures frequently on regulatory matters.  Published in technical journals, magazines, books, articles, and columns in the regulatory and pharmaceutical fields.  Member of the Scientific Advisory Board for BioLink Sciences, Inc.  Holds a regulatory affairs certification and is a fellow of the Regulatory Affairs Professiona...
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