AFDO RAPS Healthcare Products Collaborative
BIO
Lacey Harbour 2022

Lacey

Harbour

Regulatory Affairs Manager

Thermo Fisher Scientific

Lacey Harbour is a classically trained Molecular Biologist turned Regulatory, Quality, and Clinical Strategist. Her experience includes the Clinical Laboratory, R&D, Pharmaceuticals, and Medical Devices industries. Leveraging a diverse background, she has led or supported teams that have brought orthopedic, in vitro diagnostic, SaMD, dental, physiotherapeutic, and other FDA Class I to Class III devices to the 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 a passion for many years. As an advocate of protecting patients while taking a risk-based, least burdensome approach, Harbour considers joining think tanks like AFDO/RAPS as an honor. Her goal is to ensure that the future of medical care is state of the art while maintaining safety and effectiveness and, hopefully, encouraging global accessibility of good healthcare products.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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