Principal Consultant
Qserve Consultancy BV
Arnhem, Gelderland, Netherlands
Kristiane Schmidt, PhD joined Qserve Group’s IVD team as Senior Consultant in 2022. She is passionate about using her quality mindset to support the introduction of new medical technologies. She has more than 15 years of experience with product development in the in-vitro diagnostics medical device (IVD) industry, ranging from proof-of-concept research to verification/validation and implementation of product development under ISO 13485. Kristiane has hands-on experience with different technology platforms such as qPCR, immunoassays, and point-of-care devices. She also has expertise in guiding product design and development activities, preparation of technical files for IVDD/IVDR and clinical trials for IVD devices in compliance with ISO 20916.
Prior to joining Qserve, Kristiane had various roles in large multi-national corporations as well as small and medium sized companies. Kristiane has a PhD in Biophysics from University of Osnabrück and a master’s degree in biotechnology from Technical University of Braunschweig.
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Tuesday, May 13, 2025
08:30 - 16:00 CEST
Wednesday, May 14, 2025
08:30 - 09:30 CEST