Dirk Stynen has a Ph. D. in Biology and a Postgraduate Degree in Enterprise Economics (K.U. Leuven). He was a postdoctoral fellow at the University of Pennsylvania. Dirk is widely experienced in scientific research, diagnostic assay development, quality system implementation, regulatory affairs and IVD performance evaluations.
In 2000 Dirk founded Qarad, a consulting organization with offices in Belgium, the Netherlands and Italy. The company is specialized in regulations and quality system implementation for IVDs and in the organization of performance evaluations for IVD. Qarad is serving companies wordldwide. Dirk also developed Qarad’s e-labeling service allowing IVD and medical device manufacturers to distribute eIFU in full compliance with regulations and currently used by major IVD and MD manufacturers.