Medical Devices Expert Witnesses
The United States Food and Drug Administration defines medical devices as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,
- or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." There are three classes of medical devices.
Our medical devices expert witnesses
, speakers, and consultants are scholars and researchers from major universities and industry professionals who have designed and invented numerous medical devices. Areas of expertise include biomedical engineering, mechanical engineering, preclinical safety testing, sales and marketing of medical devices, plastics/polymers in medical devices, medical devices for gene therapy, safety syringes, cardiac catheters, IV devices, insulin pumps, multi-lumen catheters, pacing catheters, drug and fluid delivery systems, urinary incontinence devices, plastic part design, packaging, labeling, disposal of medical devices, patent evaluation, failure analysis, and more. They have extensive experience as expert witnesses in legal proceedings involving patent enforcement, packaging, product liability, and other issues related to medical devices. Our medical device experts
have extensive experience providing litigation support.