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.

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).

QARAD BV

ISO Certified
ISO 13485 and ISO 27001

Quicklinks

Website by Contents by Qarad Terms and conditions  Privacy policy  Cookie policy 
Close

Attention!

This website uses cookies to enhance your surfing experience.
Certain webfunctions rely on the usage of these cookies.
If you want more information regarding our cookie policy, you may visit this link.