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Key elements to consider to successfully bring your Swiss IVDs to the EU market
A high-level overview of key elements to be taken into account under the IVDR in order to gain access to the EU market. This webinar is hosted by Qarad, part of the QbD Group.

00:46:00

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Speakers

Kirsten Van Garsse
Authorised Representative Director & Regulatory Affairs Manager @Qarad (part of the QbD Group)
Kirsten Van Garsse joined Qarad at the end of 2017. Kirsten obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has gained extensive experience working in the In Vitro Diagnostic Medical Device Industry in various roles. As a Regulatory Affairs Manager within Qarad, Kirsten applies her experience to Regulatory Affairs projects, translating regulations into compliant business processes and applications. She actively gathers all relevant regulatory intelligence and oversees the writing of the company newsletters. She is also one of Qarad’s trainers on various subjects related to the  IVDR 2017/746. As Authorized Representative Director she is responsible for the representative service of Qarad, including European Authorised Representative (EC-REP), UK Responsible Person (UKRP) and Swiss Authorised Representative (CH-REP) services.