Dirk Stynen, PhD – Principal

Dr. Stynen has nearly 10 years of scientific experience in academic research and has been active for more than 20 years in the diagnostics industry in different functions. He is the founder and principal consultant of Qarad, a Belgium-based consulting company with a worldwide customer base specializing in European regulations of in vitro diagnostics and medical devices and in quality system implementation. Prior to founding Qarad, he was the Quality Assurance and Regualtory Affairs Manager at Innogenetics where he implemented an EN46001 certified quality sytem and achieved premarket approval for highly regulated diagnostic assays in various countries. At Sanofi Diagnostics Pasteur, he headed a R&D group developing monoclonal antibodies and immunoassays for fungal and bacterial pathogens. Dr. Stynen is an author on 37 peer-reviewed scientific publications and has given presentations at major conferences. He received MS and PhD degrees in Biology and a postgraduate degree in Economics from the Catholic University in Leuven, Belgium. He further held postdoctoral fellowships at the University of Pennsylvania in Philadelphia in Developmental Biology and Molecular Immunology. Dr. Stynen participates in the European Commission’s Technical Working Group on IVDs and is a member of the Regulatory Affairs Professionals Society. He is fluent in Dutch, French and German and is conversational in Italian and Portuguese.

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