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, Medical Devices - 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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Tom Wilson, MSME TGWilson Consulting LLC

Guilford, Connecticut
Biomedical Engineering, Medical Devices - 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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J. Lawrence Stevens, RAC ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts

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, 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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Joshua Sharlin, PhD SHARLIN CONSULTING

STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices - 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: My key skill is identifying and developing facts supporting a legal strategy. (1) Drug reviewer at FDA. (2) Expert witness experience: Cases-37, Expert reports-16, Depositions-8, Testimony-1, Successful Daubert challenges-0. (3) Professional experience: Regulatory consultant (25 years), expert witness (10 years). (4) My cases have involved drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance, product labeling. (5) My skills: biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert. (6) Talented technical writer, my writing experience includes:  Expert reports, scientific publications, audit reports for FDA compliance, standard operating procedures, FDA submissions, responses to questions from FDA. (7) I write custom software for data mining of safety information from FDA’s adverse event databases:  I extract f...
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Ann Prewett, PhD

Bloomfield, Michigan
Medical Devices, Products Liability - 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, Products Liability - 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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