Exponent provides the highest quality technical, regulatory, safety assessment, epidemiological, and health economics services to assist our clients with issues related to medical devices. We specialize in providing rapid, focused, market-sensitive solutions to complex issues. Our clients with issues related to medical devices face numerous challenges today to get products to market, including developing appropriate preclinical and clinical plans to evaluate safety and effectiveness and preparing compelling regulatory submissions. In addition, from a business standpoint, it is important that our clients with issues related to medical devices understand the market and reimbursement strategies for their products. Once a product is approved, there are many other issues to be addressed as part of postmarketing strategies, such as ensuring compliance with FDA Good Manufacturing Practices and appropriately documenting, evaluating, and communicating reports of medical device adverse events (Medical Device Reporting, or MDR). In addition, although no company markets a product with an expectation of having to recall it, it is imperative that contingency plans are in place when the product hits the market.

Exponent's team of more than 500 scientists, engineers, physicians, and other professionals hold advanced degrees in more than 70 disciplines. We bring a multidisciplinary approach to address a wide range of medical device issues, applying expertise in biomechanics, biostatistics, electrical engineering, epidemiology, exposure assessment, health economics, human factors, materials science, mechanical engineering, medicine, regulatory affairs, and toxicology.

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