Art 88 - Trend Reporting
Feb 06, 2020 2:00 PM - 3:00 PM
Leonard is part of the Qserve 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.