Kirsten Van Garsse

Director Authorised Representative Services & Manager IVD – Regulatory Affairs

Kirsten Van Garsse is an expert in IVD regulatory affairs with over 20 years of experience in the diagnostics industry. At QbD Group, she leads authorised representative services and manages regulatory compliance for a wide range of in vitro diagnostic devices.

Biography

Kirsten Van Garsse holds a master’s degree in biomedical sciences from the Vrije Universiteit Brussel (VUB), obtained in 2002. She brings more than two decades of experience in the In Vitro Diagnostic Medical Device Industry, where she has held various expert and leadership positions.

Since joining Qarad (now part of QbD Group) in 2017, Kirsten has played a key role in shaping the company's regulatory and quality services. As Regulatory Affairs Manager, she translates complex and evolving regulations into practical, compliant business processes. In her role as Director of Authorised Representative Services, she oversees the full suite of representation services Qarad provides to clients globally.

Kirsten’s experience spans a wide array of device types, including Companion Diagnostics, Software as a Medical Device (SaMD), and IVDs ranging from Class A to Class D. She also works with Medical Devices from Class I to IIb and is particularly well-versed in the challenging interface between pharmaceuticals and diagnostics.

In addition to her professional work, Kirsten is actively engaged in the regulatory community. She serves as a board member of the European Association of Authorised Representatives (EAAR) and is Chair of the RAPS Belgium Local Networking Group.

Establishing and maintaining the right level of clinical evidence under the EU IVDR

Kirsten's key areas of expertise

IVDR implementation & strategy

Guiding manufacturers through the full IVDR lifecycle—from gap assessments to CE marking.

Authorised representation

Managing EU representation and ensuring compliance for non-European manufacturers under IVDR.

Regulatory Affairs for IVDs & Medical Devices

Hands-on experience with a wide variety of IVDs and Medical Devices, including SaMD and Companion Diagnostics.

Pharma-Diagnostics Interface

Deep understanding of the complex regulatory overlap between pharmaceutical products and diagnostic devices.

Explore our expert content

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Mastering Clinical Performance Studies under IVDR

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Clinical evidence for In Vitro Diagnostics under IVDR

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EUDRALEX Volume 4 Annex 11 Compliance Checklist

Assess your computer system's compliance with EudraLex Volume 4 Annex 11 guidelines using our checklist. Download now for GMP assurance.

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IVDR Extension Explained: Tips & Strategies

Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.

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The journey toward IVDR compliance for the LVOne device

QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

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