IVD Product Development, PMS
Senior Consultant
Introduction
Since January 2022 Kristiane has joined the Qserve Group as senior consultant where she’s part of the IVD team. Her focus areas are IVD product development, ISO & CE marking including PMS.
Kristiane about working at Qserve
I am passionate about applying my experience in IVD product development and my quality mind-set to support the introduction of new medical technologies that improve patients’ lives.
I am excited about working with and learning from such an experienced team of experts.
Before Qserve
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 ranging from proof-of-concept studies to verification and validation.
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