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Uschi Oudt MSc. MDM has extensive experience in quality management and regulatory affairs within the medical device industry. Currently serving as a Quality professional at Prolira BV since April 2019, Uschi contributes to the development and continuous improvement of the Quality Management System and Technical File. Prior to this role, Uschi served as QA/RA Manager at NightBalance, where responsibilities included establishing a robust QMS for medical devices treating sleep apnea and supporting product certification. Uschi also held the position of Quality Manager at Hittech MPP, maintaining ISO 9001 standards, and BabyBloom Healthcare BV, ensuring compliance with ISO 13485 and MDD regulations. Earlier in career, Uschi worked at Mentor Medical Systems BV as Associate Director R&D and Manager R&D, focusing on breast implant product innovation. Uschi’s educational background includes a Master of Design Management from EURIB and a Master’s degree in Industrial Design from Delft University of Technology.