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Meet BWE Phenomenal Woman Lori-Ann Archer… read why

Lori-Ann Archer, CQE, CMDA, CSQA, is a Cornell University Alumni of the Electrical Engineering Department. She has over 25 years in the medical device and combination products industries as a quality engineering and quality systems subject matter expert and executive leader.  Holding three certifications from the prestigious American Society for Quality, Lori-Ann has an impressive track record of building outstanding quality management systems for medical devices and drug delivery systems (combination products) to meet U.S and international regulatory requirements. Lori-Ann implemented successful U.S. and international quality systems at top companies like Google, Teva Pharmaceuticals, Medtronic and multiple startups for medical device products such as artificial intelligence and machine learning driven software as a medical device (AI/ML SaMD), biologic and pharmaceutical drug delivery systems, implantables, and IVDs. Lori-Ann has recently dedicated herself to be an advocate and thought leader for the equitable development of medical devices and collaborated with the Cornell Biomedical Engineering Medical Device (CUBMD) team to release a white paper on this critical issue. She also seeks transparency of including the percentage of safe/real ingredients in cosmetics and released a white paper which proposes a new standard in this industry. You can follow her on LinkedIn and her free QAFE Substack Newsletter subscription.

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