Agnes Goris

Quality Director IVD Projects

Meet Agnes Goris.

Agnes Goris (born 1961, Belgian citizen) obtained a Master Degree in Biology and a Postgraduate Degree in Biotechnology at the Catholic University of Leuven. After 16 years working in the IVD industry, Agnes joined Qarad in 2002. In the meantime, she became Quality Director of IVD Projects.
In this function, she combines her Regulatory knowledge with her practical IVD experience to guide her team to excellence. Agnes can ensure smooth introduction of your products to the European market, since she can assist you with:
  • Organization and monitoring of performance studies of In Vitro Diagnostic assays
  • Composition and review of technical documentation for In Vitro Diagnostics and other Medical Devices
  • Follow-up of submissions with Notified Bodies.
  • Notification of IVD/MD to different European Competent Authorities
  • CLP and REACH requirements for IVD products

Previous experience