IVD Development, CLSI expert
Diane joined Qserve in January 2020 and is located in the San Francisco Bay area. Her experience working in the IVD and medical device industries spans 35 years and includes supporting start-ups through multi-national manufacturers. Some areas of expertise include immunoassay, flow cytometry, PCR, array, and next generation sequencing. Within Qserve she is into the IVD Development, Analytical and Clinical Study design.
Diane has worked with various levels of complexity, including companion diagnostic products. She also has extensive experience in systems development, IVD study design, design control and new product development of clinical diagnostics.
Diane earned her Bachelor of Science in Microbiology and Immunology from the University of California (Berkley) and also earned a PhD in the same field at the University of Arizona.
The key expertise areas of Diane
- Design control and requirements writing
- US FDA submissions, pre-submissions, 510(k) and PMA
- Product development life-cycle management
- Verification, validation and analytical study designs and analyses to support global submissions
- IVDR performance evaluation planning and requirements development
- Team management
- Best practices for development of IVDs (analytical study designs, setting acceptance criteria based on design requirements and intended use)
- Evaluating trade-offs during assay cutoff determination
- Collaboration with biostatisticians in biology aspects of technology under development, and impacts on the study designs
- Reviewing pre-submission documents; working with presenters
- Aiding teams in responding to FDA questions regarding PMA and 510(k) submissions
- CLSI expert