RAPS Global Regulatory Strategy Conference 2025

Sara Van Wouwe graduated with a Master’s in Clinical Biomedical Sciences from the Catholic University of Leuven, where she gained experience in clinical scientific research.

She started at Qarad in 2017 to assist the Authorized Representative Team. During this period, she gained knowledge in the review of technical documentation, the notification of devices to the Belgian and Dutch authority, and the responsibilities of the UK Responsible Person. While still supporting the Authorized Representative Team, Sara became part of the Device Compliance Team where she has supported dozens of our customers with the review and writing of their Technical Documentation according to Annex II and III of the IVD-R 2017/746, gap analyses, writing of Clinical Evidence documentation as well as Scientific Validity Reports.

Pieter Bogaert is an IVD specialist with a wealth of experience in flow cytometry. Pieter graduated with a Ph.D. in Biotechnology at Ghent University, after which he stayed on to work there. He later expanded his knowledge by working as a Flow Cytometry specialist at BD Biosciences and Cerba Healthcare. Pieter has written multiple articles, published in various international, peer-reviewed journals.

At Qarad, Pieter’s responsibility is to ensure compliance of IVD product technical documentation with the European Regulation. This includes gap assessment and other consulting services, as well as technical file writing and compilation. Given his previous professional experience, Pieter’s in-depth areas of expertise are medical laboratory devices, clinical flow cytometry reagents and instruments.