Qarad has excellent, in-depth knowledge of IVDs and the related regulations. We have an exceptional team with knowledge in diverse fields such as immunoassays, next gen sequencing, PCR test, flow cytometry and much more. 

Our consultants have many years of experience in the field and are all highly qualified to protect your regulatory interests. 

We also cooperate with a wide network of selected professionals and professional organizations, who contribute to Qarad’s high quality services in different ways.
 

Management

Maurizio Suppo, Ph.D.

Co-owner and Vice-President

Maurizio Suppo obtained his Ph.D. in Molecular Biology from the University of Turin. He held executive positions at several world-renowned IVD companies and was director of the European Diagnostic Manufacturers Association (EDMA).
Maurizio joined Qarad in 2012 and became co-owner in 2016

 

Team

Each of our services is supported by high-quality employees, who are always ready to help you with all your questions. Click on a service below to get to know our experts!

Device Compliance Team

Wisdom, Purposeful

eIFU Service team

Unique, Adaptive, Patient

Performance Studies Team

Organized, Helpful, Communicative


 

Authorized Representative Team

Leader, Courage, Strength

Scientific Validity Team

Fast, Agile, Strength, Alert

Sales Team

International, Support, Connectivity

Agnes Goris

Quality Director IVD Projects

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 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).

Sue Schiepers, MBA

Business Operations Manager & Privacy Manager

Sue Schiepers graduated in Art Sciences, after which she obtained a post-graduate degree in Corporate Economics from the Catholic University of Leuven. She expanded her knowledge by obtaining an Executive MBA at the Antwerp Management School. Sue joined Qarad in 2019 as Business Operations Manager. She assists the management in organising day-to-day activities of Qarad and as such Sue is responsible for Human Resources, office management, finances and much more. 

Rika Verduyckt

Office Assistant

QARAD BV

ISO Certified
ISO 13485 and ISO 27001

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