US Principal Consultant
Leonard is part of the US Regulatory Affairs team providing biostatistical and clinical perspectives from a manufacturer’s point of view having led and served on multiple successful product core teams. Areas of expertise include biostatistics, product development life cycle management, verification, validation and optimization study designs and analyses, clinical operations and team management.
This spans a variety of novel and traditional in vitro diagnostics and medical devices across a wide product portfolio. His main activities at Qserve are biostatistical support, US FDA submissions, pre-submissions, IDE, 510(k), PMA), and CE-Mark Technical File and Clinical Evaluation Report analyses.
Leonard has over 35 years’ experience working in the IVD and medical device industries. Working with small startups all the way to large multinational companies. Some product areas include, immunoassay, flow cytometry, lateral flow, PCR, array and next generation sequencing, peripheral vascular and drug releasing pulmonary devices. He has worked with all levels of complexity from CLIA waived products to companion diagnostic products. Leonard is experienced at assessing whether or not there is sufficient evidence to support the product claims.
He earned his B.S. in Biology (UCDavis), M.S. in Biology (CalPolySLO) and M.S. in Biometry (Medical University of South Carolina).
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