Palmer Smith, M.Eng.

Palmer Smith, M.Eng.

Senior Associate, Spine Regulatory Affairs
Background

Palmer Smith brings over three years of regulatory affairs experience to MCRA’s team. Palmer specializes in spinal devices, but has assisted clients in the orthopedic, wound care, urology, and neurology markets. Palmer’s work has led to the clearance of multiple 510(k)s and approval of numerous Breakthrough Device Designations and IDEs. His goal is to develop, through client-collaboration and extensive knowledge of the regulatory landscape, robust strategies that efficiently bring the clients’ devices to market.

Education

Palmer holds a Master of Engineering in Biomedical Engineering from Clemson University, as well as a Bachelor of Science in Biomedical Engineering from Clemson University.

Experience

Before joining MCRA in February 2021, Palmer worked for the Clemson University Research Foundation where he helped identify and commercialize promising technologies developed by the school’s researchers.

Palmer Smith is responsible for the development of Q-Submissions, 510(K)s, De Novos, Breakthrough Device Requests, IDEs, and PMAs. Palmer helps clients navigate intensive regulatory landscapes by developing strategies and recommendations that efficiently bring their devices to market. Palmer collaborates across all MCRA service arms to ensure all clients’ pre-market needs are met. Additionally, Palmer helps lead the Compassionate Use Program service at MCRA that provides clients and physicians a unique FDA-pathway to better treat patients. Palmer has worked in multiple therapy areas, including spine, orthopedic, wound care, and biocompatibility, as well as other cross-therapy devices beyond MCRA’s standard therapy divisions.

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