IVD Manager Device Compliance & Performance Evaluation Studies
Qarad
Annelies Rotthier joined QARAD in 2020 as Device Compliance Manager. During her Ph.D. in Molecular Genetics at the VIB Institute in Antwerp, a passion for molecular genetics diagnostics grew after observing the impact of a correct diagnosis on patients and their relatives. She pursued her career in the field of molecular genetics as R&D manager in the spin-off company Multiplicom, where she was responsible for the development of IVD reagents for Next Generation Sequencing and later as Director Product Development at Agilent Technologies, a major player in Next Generation Sequencing IVD applications. Besides expertise in molecular genetics, her experience of working in a fast-growing spin off company brought her a pragmatic and hands-on approach.
At Qarad, Annelies brings her technical and regulatory expertise to the composition and review of technical documentation in line with the European IVD Regulation. She provides consulting on various IVD-R related topics. She manages the team responsible for technical writing and reviewing of IVD-R compliant documentation.
Disclosure information not submitted.
Maintaining Compliance: IVDR Post-Certification Activities
Wednesday, May 8, 2024
11:45 – 12:45 CEST