Kristina Fant (PhD), Director for Biological Safety at GBA Key2Compliance.
She has been working with biological evaluation of medical devices for the past 11 years. She has extensive experience in testing of medical devices and GLP, from her previous work at RISE (Research Institutes of Sweden) where she has worked as a Study Director and Deputy Facility Manager. She has also assisted the Swedish national monitoring agency Swedac during GLP inspections.
She has special interest in the 3Rs, i.e, replacing animal testing with alternative testing methods, and is a delegate of the Swedish National Committee for the Protection of animals used for scientific purposes, steering group for the Swedish 3Rs center.
She is a Standard Developer as member of the Swedish standardization committee (SIS TK 340) responding to ISO TC194, developing the ISO 10993 series.
She has a broad knowledge regarding medical devices, GLP and the corresponding regulatory framework as well as an extensive experience in interdisciplinary work and research.
