Christèle has been in the medical technology industry for over 20 years with ten years focused on In Vitro Diagnostics (IVDs). She gained most of her experience on IVD product development in small biotechnology companies. As a Research and Development Manager for AmikanaBioLogics, she developed a new variety of biological tools for implementation in microbiology laboratories using the yeast cell as a cellular reader of drug resistance. Within HalioDx, an immuno-oncology diagnostic company, she contributed to the development of IVD products and services for their immunohistochemistry platform and served as a Quality control Manager for a PCR kit.

Just prior to joining NAMSA, Christèle worked for nexialist, a consulting company specializing in regulatory intelligence and compliance of health products. As a Medical Device and IVD Consultant, she was involved in ensuring compliance with classification, CE-mark technical documentation, performance evaluation within IVDD/IVDR frameworks, regulatory support, biological risk assessments (plans, reports), clinical evaluations and post-market surveillance.

Christèle obtained her PhD in Cellular Biology from University of Joseph Fourier, Grenoble (France). After several years working on the development of IVDs, she also completed a University Diploma in Clinical Research at the Faculty of Medicine of Marseille. 

CORE COMPETENCIES

• Technical documentation for IVD devices for IVDR compliance/CE Marking and FDA submission such as 510(k) for novel, standard and legacy devices
• R&D product development cycle (i.e. scope, feasibility, verification and validation) leading to CE Mark for IVD assays (PCR and immunohistochemistry assays)
• Creating, evaluating and training on documentation such as: Performance Evaluation, Post Market Surveillance, Analytical Performance, Clinical Performance, Scientific Validation, GSPRs, STED, Regulatory Assessments
• Experience in several IVD areas such as Clinical Biochemistry, Haematology, Infectious Disease, Diabetes, Oncology, Companion Diagnostics for professional and home use
• Development of regulatory and clinical strategies including regulatory pathways, IVDR transition strategies

RECENT PROJECTS

• In Vitro Diagnostic Regulation (IVDR) multi-geographic regulatory assessment project, addressing weaknesses in the technical documentation and developing technical documentation for the IVDR/U.S./NMPA submission
• IVDR transition project for two multinational IVD manufacturers, addressing weaknesses in the technical documentation and development of technical documentation for the IVDR
• Provided regulatory support for projects involving CDx
• Preparation of Technical Documentation to support EU IVDR 2017/746 compliance for oncology, infectious disease, microbiology, and pregnancy assay