Since January 2022 Kristiane has joined the Qserve Group as senior consultant where she’s part of the IVD team.
Kristiane about working at Qserve
I am passionate about applying my experience in IVD product development and quality mind set to support the introduction of new medical technologies that improve patients’ lives. I am excited about work with and learn from such an experienced team of experts.
Kristiane has more than 15 years of experience in IVD product development, ranging from proof-of-concept research to verification/validation and implementation of product development under ISO 13485. She has hands-on experience with different technology platforms such as qPCR, immunoassays, and point-of-care devices She also has expertise in the pharma industry, including development of companion diagnostics and Clinical Trial Assays. Kristiane has worked in large multi-national corporations as well as small and medium sized companies.
Prior to joining Qserve, Kristiane was holding a role as Program Manager developing multiplex proteomics biomarkers for therapy prediction in oncology. Her responsibilities included preparation of the technical files for CE-IVD marking under IVDD/IVDR as well as leading risk management activities under ISO 14971 and performance evaluation studies.
Kristiane has a PhD in Biophysics from University of Osnabrück and a master’s degree in biotechnology from Technical University of Braunschweig.
The key expertise areas of Kristiane:
- Implementation of IVD product development under ISO 13485 including establishing design control and design history files
- Advising on IVD biomarker development, verification and validation study designs and analysis
- Strong technical background in different platforms such as qPCR, immunoassays and point-of-care devices
- Application of ISO 14971 risk management including hazards analysis, design and use FMEA, and risk mitigation
- Translation of intended use and user needs into acceptance criteria and product design requirements
- Documentation and review of design history files, device master records, and technical files for IVDD and IVDR
- Guiding clinical trials for IVD devices in compliance with ISO 20916
- Project Management skills, experienced in working with multidisciplinary cross-functional teams
- Language skills: English fluent/professional, German native speaker, Dutch fluent/professional