Senior Consultant
Qserve Group, Netherlands
Kristiane Schmidt, PhD joined Qserve Group’s IVD team as Senior Consultant in early 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, risk management activities for ISO 14971 and project management.
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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Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
Friday, May 12, 2023
10:45 – 11:45 CEST