Semler Scientific
Gena D. Parker serves as the Vice President of Regulatory Affairs, Quality Assurance, and Compliance at Semler Scientific since April 2020, overseeing regulatory, quality system, and compliance activities in accordance with FDA QSR's, ISO 13485, MDSAP, MDR, and HITRUST standards. Gena has a robust background in regulatory affairs, having held multiple leadership roles including Associate Vice President and Director of Regulatory Affairs, Quality Assurance, Quality Engineering & Compliance at Semler Scientific, where responsibilities included developing comprehensive regulatory strategies and engaging with various health authorities and stakeholders. Prior experience includes directing quality assurance and regulatory affairs at Phoenix DeVentures and managing document control at several medical device companies. With a career spanning over two decades, Gena D. Parker has extensive expertise in navigating complex regulatory environments and ensuring compliance across diverse product portfolios.
Semler Scientific
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Semler Scientific, Inc. is a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers. Semler Scientific's mission is to develop, manufacture and market innovative products that assist its customers in evaluating and treating chronic diseases. Semler Scientific commercially launched its first patented and FDA- cleared product in 2011, and received FDA 510(k) clearance for QuantaFlo®, the next generation version of this product, in 2015. QuantaFlo® is a rapid point-of-care test that measures arterial blood flow in the extremities to aid in the diagnosis of peripheral arterial disease. QuantaFlo® is used by Semler Scientific's customers to more comprehensively evaluate their patients for risk of heart attacks and strokes. Semler Scientific believes it is positioned to provide valuable information to its insurance company and physician customers, which in turn permits them to better guide patient care.