Post-Market Surveillance Requirements for Medical Devices and IVDs

Kirsten Van Garsse

Direcor Representative Service & Manager IVD Regulatory Affairs

Kirsten Van Garsse obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has amassed extensive experience in the In Vitro Diagnostic Medical Device Industry. She joined Qarad, now part of the QbD Group, a consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, at the end of 2017. In her role as Director of Authorized Representative Services & Manager of IVD Regulatory Affairs, Kirsten applies her wealth of experience to Regulatory Affairs projects, adeptly translating regulations into compliant business processes and applications. Additionally, she oversees the various Representation Services offered by Qarad, ensuring clients receive expert support in navigating regulatory requirements.

Anne-Sophie Grell

Manager Regulatory Affairs Medical Devices

Anne-Sophie Grell – PhD in Physics and expertise as a Medical Physicist – brings over 20 years of invaluable experience in the areas of Medical Device Quality Assurance (QA) and Regulatory Affairs (RA). As a seasoned Regulatory Affairs Manager, she has consistently demonstrated her proficiency in navigating the complex landscape of medical device regulations. With her extensive knowledge and comprehensive understanding of the industry, Anne-Sophie is a respected authority in ensuring compliance and driving successful outcomes in medical device regulatory affairs.