Women in Medtech 2021: Shannon Hoste, Agilis Consulting Group President

Shannon Hoste {Image courtesy of Agilis Consulting Group]

Shannon Hoste is the president of Agilis Consulting Group and an assistant professor in the Quality Science Education program at Pathway for Patient Health. She is active on several standards and conference committees for medical devices and combination products.

Hoste formerly worked as team lead for human factors in FDA’s Center for Devices and Radiological Health (CDRH) and as a reviewer within the Center for Drug Evaluation and Research (CDER). At the FDA, she led reviews of human factors data for medical device premarket submissions through 510(k), PMA and De Novo pathways, combination products through NDA, BLA, ANDA pathways, as well as data to support IND and IDE requests.

Outside of Shannon’s work for the FDA, she continues to build on her 25-plus-year career in the medical device, IVD and combination product industry as an R&…

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