Device Compliance Expert
Meet Sara Van Wouwe.
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.