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

Kirsten Van Garsse, RCC-IVDR (she/her/hers)

Director Authorised Representative Services & Manager IVD - Regulatory Affairs
Qarad (Part of the QbD Group)
Wilrijk, Antwerpen, Belgium

Kirsten Van Garsse holds a master’s degree in biomedical sciences from the Vrije Universiteit Brussel (VUB), obtained in 2002. With over two decades of experience in the In Vitro Diagnostic Medical Device Industry, she has excelled in various roles.

Since joining Qarad, now part of the QbD Group, in 2017, Kirsten has been pivotal in driving regulatory compliance and quality initiatives. As a Regulatory Affairs Manager, she translates complex regulations into compliant business processes while in her role as Authorized Representative Director, she oversees all Representation Services offered by Qarad.

Kirsten has extensive experience across various device types, including Companion Diagnostics, Software as a Medical Device (SaMD), a diverse range of IVDs from Class A to Class D, and a diverse range of Medical Devices from Class I to IIb. She is also highly knowledgeable in matters related to the complex interface between pharmaceuticals and diagnostics.

Disclosure information not submitted.

Presentation(s):

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