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With a background in interdisciplinary social sciences, Christina has been trained in various qualitative research methods. Her human factors expertise includes consulting on products from early-stage exploratory research through end stage validation studies, and she has supported several successful submissions. She collaborates with clients to design programs of research and decide on optimal methodologies, while supervising individual research projects involving medical devices and digital health management platforms. Christina holds a BA in Comparative Human Development and an MA in the Social Sciences from the University of Chicago.
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Finding efficient ways to leverage post-market surveillance data to inform product development at an institutional level will be key for SaMD manufacturers seeking FDA precertification.
Healthcare symposium provides clarity for interpretation of FDA guidance documents related to human factors engineering.