Device Compliance Team

  

Annelies Rotthier, Ph.D.

Senior Consultant and Device Compliance Manager

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.

 

Pieter Bogaert, Ph.D.

Device Compliance Expert

Pieter Bogaert is an IVD specialist and more specifically, he has a wealth of experience in flow cytometry. Pieter graduated as Doctor in Biotechnology at Ghent University, after which he started to work there. Later on, he expanded his knowledge by working as 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 ways of consulting as well as technical file writing and compilation. Given his previous professional experience, Pieter's in-depth areas of expertise are medical laboratory devices and clinical flow cytometry reagents and instruments.

 

Jessie Theuns, Ph.D. 

IVD Expert

Jessie worked at the University of Antwerp as a professor for more than 20 years, then switched to Multiplicon, and later Agilent.

 

Miranda Van Hoof

Device Compliance Expert

Miranda Van Hoof graduated in Pharmaceutical and Biological Techniques in Brussels. Afterwards, she gained experience as Quality and Regulatory specialist at Tosoh Bioscience (former Eurogenetics). As IVD expert, Miranda joined Qarad in 2019 as part of the Device Compliance team. Miranda assists non-EU manufacturers with the review of their Technical Documentation and notification of their products as Authorized Representative. Moreover, she also writes Performance Evaluation Plans and Reports, as well as performing gap analyses to comply with the relevant regulations.  

 

Sara Van Wouwe

Device compliance Assistant

Sara Van Wouwe graduated 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 Device Compliance team. Meanwhile, Sara has assisted dozens of our customers with the review of their Technical Documentation, gap analyses, writing of Clinical Evidence documentation as well as Scientific Validity Reports. 
 

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ISO 13485 and ISO 27001

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