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Learning Level: Advanced
Learning Level: Advanced
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Learning Level: Intermediate
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Gaëlle Bisch, PhD (she/her/hers)

Product Assessor
GMED, France, Ile-de-France, France

Gaëlle BISCH joined GMED in 2019 and is currently a Product Assessor within the IVD Certification team. She also is a technical and regulatory expert for IVD software, including those using Artificial Intelligence. Her roles are mainly the assessment of IVD software for various clinical applications, training of Product Assessors, and supporting the team on all questions related to IVD software. She also has been involved in the writing of guidance documents as well as giving talks regarding the application of IVDR and state-of-the-art standards to IVD software. Before joining GMED, Gaëlle has participated to the design and CE-marking of IVD medical software for antibiotic resistance testing, and has been a researcher in the field of bacterial evolution. She holds a PhD in microbiology and parasitology from the University of Montpellier, France.

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