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Learning Level: Foundational
Learning Level: Foundational
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Learning Level: Intermediate
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Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Networking Event
Networking Event
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Sponsor Presentation
Ticketed Event
Ticketed Event

Sara Van Wouwe, RCC-IVDR (she/her/hers)

Senior Consultant IVD - Regulatory Affairs
Qarad (part of the QbD Group)
Wilrijk, Antwerpen, Belgium

Sara holds a master's degree in clinical biomedical sciences and joined Qarad in 2017. She has extensive knowledge of the IVD-Regulation 2017/746, gained through supporting dozens of customers in successfully obtaining notified body approval. In 2024, Sara achieved her RCC-IVDR certification, further cementing her expertise in regulatory compliance. She is experienced in Annex XIV submissions for IVD performance studies and serves as the subject matter expert at Qarad for labeling and instructions for use. As a regulatory affairs consultant for IVDs, Sara also supports start-ups aiming to bring innovative IVDs to the market. Sara is also the Program/Educational Chair of the RAPS Belgium Local Networking Group.

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Presentation(s):

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