FDA Expert Witness

Listings

Fda expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on fda. The fda expert witness listings on this page are typically from fields/areas of expertise such as: Biomedical Engineering, Intellectual Property, Medical Devices, and Pharmaceutical Regulation.

Unable to find the right fda expert? Contact us for personalized assistance locating an expert witness.

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 including ITC and PTAB matters. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 25 U.S. Patents with several pending. 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 Physics from Oxford University as well as Doctorate from Oxford in Mate...

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 ...

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...