HepQuant Makes Change To Regulatory Team
Adds Support of Fang Consulting
DENVER (Oct. 31, 2017) — HepQuant, LLC, a Greenwood Village, Colo.-based company with a unique, patented and patent-pending technology for evaluating the liver in patients with chronic liver disease, today announced it has hired Fang Consulting of Minneapolis to supplement the strategic, regulatory and quality assurance efforts John Van Hoven and Chris Pappas have been providing HepQuant for the past several years. Tracy Eberly of Fang Consulting will hold a position as Director of Quality Assurance and Regulatory Affairs for HepQuant.
Tracy, brings more than 30 years of medical device industry experience in FDA Regulatory Affairs, EU and CE Marking, and International Organization for Standardization (ISO) reviews and auditing. His experience has also included guiding medical device approvals in Canada, Australia, Japan, Mexico Columbia, Brazil, South Korea, South Africa, Taiwan, Thailand, Iran, South Africa, Egypt, Lebanon, Israel, Russia, and China.
As a key Principal of Fang Consulting over the past 18 years, Tracy has helped numerous medical device companies and healthcare providers navigate a wide range of regulatory pathways, both domestically and internationally. He is also experienced in Quality Systems as well as various storage and distribution solutions for medical devices. His portfolio of clients has included Medtronic, St. Jude Medical, Boston Scientific, Devicix, Spectranetics, Abbott, Fresenius Medical, Cardinal Health Johnson & Johnson, Covidian and GE Healthcare. Mr. Eberly holds a Bachelor of Science degree from the University of Minnesota.
Tracy is joined by two colleagues from Fang Consulting, Laura Lind and Alexandra Carlson.
As Manager of Regulatory Affairs, Laura Lind will help manage HepQuant’s efforts with national and international regulatory bodies. She brings more than a decade of experience in a variety of regulatory roles and submission pathways including US, Canada, EU, 510(k) strategy and planning, CE Marking, support for Japan submissions, product development support and detailed assessment of changes.
Laura has previously served as Senior Regulatory Affairs Consultant, Senior Regulatory Affairs Specialist at Nonin Medical, Regulatory Affairs Consultant at American Medical Systems, Senior Regulatory Affairs Specialist at Covidien Vascular Therapies (now Medtronic) and Regulatory Affairs Specialist for Cardiac, Rhythm and Vascular (CRV) Group at Boston Scientific. Her prior experience before joining the Medical Device industry includes Energy Marketing, Contract Administration and several engineering positions in the electrical and gas power industries.
Laura holds a Bachelor of Science degree in Nuclear Engineering from Iowa State University.
Ms. Alexandra Carlson will serve as Manager of Quality Assurance. Alex is responsible for HepQuant’s Quality Management System. She brings experience as a Certified ISO Auditor (13485:2016), internal audits, electronic medical device reporting systems and quality system documentation.
Prior to her experience at a regulatory affairs consulting firm she served as Quality Engineer at Torax Medical an early stage medical technology company focused on minimally invasive treatments for digestive, incontinence and obesity disorders. Alexandra earned a Bachelor of Science degree in Biomedical Engineering, with a minor in Biological Sciences, from Marquette University.
John Van Hoven and Chris Pappas will continue to consult for HepQuant in collaboration with Fang Consulting as HepQuant expands the development of its unique and promising technology for assessing liver function in patients with chronic liver disease.
Headquartered in Greenwood Village, Colorado, HepQuant, LLC, is a privately-held, early-stage combination drug and in-vitro diagnostic company. HepQuant’s products are investigational combination drug and in-vitro diagnostic devices and have not yet been evaluated or reviewed by the US Food and Drug Administration (FDA) for commercial sale. They are currently available for investigational use via the FDA IDE application process. For additional information, please visit our website at www.hepquant.com.
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