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Lacey Harbour is a Regulatory Affairs Manager at Thermo Scientific with over 15 years experience that ranges from the Clinical Laboratory, Clinical Studies, R&D, Pharmaceuticals, and Medical Devices industries. Leveraging her diverse background, she has led and/ or supported teams that have brought orthopedic, in vitro diagnostic, SaMD, dental, physiotherapeutic, and other FDA Class I to Class III devices to the US and global market with high quality.
Starting from the exposure of validating predictive systems in the operational and diagnostic sides of the clinical laboratory, proving safety and effectiveness of machine learning algorithms in the total product life cycle of healthcare has been her passion.