Kirsten Van Garsse holds a master’s degree in biomedical sciences from the Vrije Universiteit Brussel (VUB), earned in 2002. With more than two decades of experience in the in vitro diagnostic (IVD) and medical device sector, she has established herself as a strategic leader known for shaping regulatory frameworks and guiding organisations through complex compliance landscapes.

Since joining Qarad (now part of QbD Group) in 2017, Kirsten has been a key driver of the organisation’s regulatory and quality capabilities. As Director Authorised Representative Services & Manager IVD – Regulatory Affairs, she leads the IVD Regulatory Affairs business unit and oversees a comprehensive suite of regulatory and representation services supporting companies across the diagnostics industry. Her expertise spans the full IVD lifecycle, with a strong focus on companion diagnostics and diagnostics used by pharmaceutical companies in clinical trials, including co-development pathways that require deep regulatory insight and cross-sector alignment.

Kirsten’s background covers a broad range of IVD technologies and classifications, from Class A to Class D devices, including Companion Diagnostics and Software as a Medical Device (SaMD). She is recognised for her ability to translate evolving regulatory requirements into clear, pragmatic strategies that support innovation, operational efficiency, and sustainable growth.

Beyond her organisational leadership, Kirsten plays an active role in shaping the regulatory ecosystem. She serves on the board of the European Association of Authorised Representatives (EAAR) and chairs the RAPS Belgium Local Networking Group, contributing to discussions and initiatives that influence the future direction of IVD regulation in Europe.