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
In the last 10 years, Agnes has managed Performance Studies for many customers for different types of IVD products including HIV, HBV, HCV, syphilis, CMV markers and ABO typing reagents.
Previous experience
Before joining Qarad, Agnes worked for major companies such as Sanofi Diagnostics Pasteur, Innogenetics N.V. (now: Fujirebio) and Genzyme where she held functions in R&D (development of immunodiagnostic assays for microbiological markers, HIV and HCV), Quality Control (batch release, method validation and implementation of statistical process control) and Regulatory Affairs (compilation of registration files).
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