Dirk Stynen is guest speaker at our awareness training IVDR.
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.
Dirk is the founder and president of 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. Each year, Qarad is offering its services to more than 150 companies worldwide.
Dirk also developed Qarad’s e-labeling service allowing IVD and medical device manufacturers to distribute eIFU in full compliance with regulations.