Jim Fentress

Director of Research & Development and Regulatory Policy

Jim brings to Gilero more than 20 years of disposable medical device experience, with a strong foundation in device design, manufacturing, process development, validation, and experiment design. Before coming to Gilero, Jim worked in product development, manufacturing, and research and development at Becton Dickinson and CareFusion. Prior experience focused on long-term device and drug development, high-volume disposable devices, needle-free access devices, pump systems, and anti-microbials. In his role as Director of Research & Development and Regulatory Policy at Gilero, Jim focuses on novel product development with new technologies, materials, or requirements. Jim also acts as a technical consultant on traditional development products providing guidance for design verification and validation testing, test method development, regulatory submissions, and regulatory body correspondence. Jim holds a degree in Biomedical Engineering from Rensselaer Polytechnic Institute.

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