Vident Partners provides vetted medical device expert witnesses for cases involving implant failures, device design defects, FDA 510(k) and PMA clearance disputes, post-market surveillance lapses, and product liability claims nationwide. Request a referral today.
Find a Medical Devices Expert →Overview
Medical device experts evaluate the design, manufacture, labeling, and clinical use of implants, instruments, and diagnostic equipment to determine whether a device met regulatory and engineering standards 1. Attorneys retain these experts to address FDA clearance pathways, design and manufacturing defects, adequacy of warnings, and the causal relationship between a device failure and patient injury. FDA classifies devices into three classes: Class I (general controls), Class II (requiring 510(k) clearance demonstrating substantial equivalence to a predicate device), and Class III (requiring premarket approval, or PMA, based on safety and effectiveness evidence) 23. Their analysis often spans the 510(k) and premarket approval processes, post-market surveillance, and recall history 4. They help establish both product defect and the medical causation linking the device to harm.
Class III medical devices — those that support or sustain human life or present a potential unreasonable risk of illness or injury — require FDA Premarket Approval (PMA) based on a scientific review of safety and effectiveness evidence before they may be marketed.
Case Types
Implant failure and premature device fracture or migration
Design and manufacturing defect claims under product liability
FDA 510(k) and PMA clearance and labeling disputes
Inadequate warnings and failure-to-warn allegations
Post-market surveillance and recall response failures
Qualifications
Related Specialties
FAQ
A qualified expert should have direct experience with the device category at issue, whether through clinical use, device engineering, or FDA regulatory work, and familiarity with the 510(k) and premarket approval pathways. Board certification in the relevant clinical specialty or advanced biomedical engineering credentials, plus prior testimony experience, are important.
These experts are retained in product liability cases involving implant failures, design and manufacturing defects, inadequate warnings, and disputes over FDA clearance or recall handling. They are also engaged to establish causation between a device malfunction and patient injury.
In general, medical expert fees are determined by the expert themselves, based on a variety of criteria. Among those criteria are clinical experience, forensic experience, academic qualifications such as Fellowships, clinical settings, and publications. Vident does have some influence over expert fees by comparing experts within a specialty, but ultimately it is a personal decision by the expert.
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Vident Partners connects attorneys with qualified medical devices expert witnesses. Complimentary consultation, 24-hour turnaround, no obligation.
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