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 managed Performance Studies for many customers for different types of IVD products, like HIV, HBV, HCV, Syphilis, CMV markers, ABO typing reagents.

As head of QARAD’s Authorized Representative Operations she is responsible for the representation of non-EU IVD and MD manufacturers based in the US, Asia and Australia (product notifications, cooperation with competent authorities on vigilance cases, provision of legalized certificates of free sales).  

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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