Overview
Medical device consulting addresses FDA regulation, design and manufacturing standards, post-market surveillance, and the clinical performance of devices ranging from implantables to diagnostic equipment. MDT Expert Consulting provides access to biomedical engineers, clinical specialists, regulatory affairs executives, and former FDA device center personnel who evaluate whether device manufacturers, distributors, and healthcare providers met applicable standards in device design, labeling, and clinical use.
Pre-Litigation Support
Pre-litigation medical device review helps counsel assess the merits of product liability, regulatory noncompliance, and clinical negligence claims involving medical devices. Experts evaluate 510(k) and PMA submissions, design history files, complaint records, and adverse event reports to assess whether the device at issue was defectively designed, improperly labeled, or inadequately monitored after market clearance.
Litigation Support
During litigation, medical device experts assist in interpreting technical design specifications, evaluating manufacturing quality systems, and assessing whether the device's clinical performance was consistent with its cleared or approved indications. They help counsel frame discovery around design files, failure analysis records, and FDA correspondence, and they evaluate the methodologies used by opposing technical experts.
Arbitration Support
Medical device experts in arbitration address commercial disputes involving distribution agreements, licensing arrangements, and supply contracts, as well as regulatory compliance disputes between manufacturers and healthcare systems.