81007 Training Biomedical Engineers in Regulatory Science: Critical Role of Experts from Industry and FDA

ABSTRACT IMPACT: Lack of regulatory knowledge and education is a key barrier to the translation of medical devices and we describe the design and results for a university graduate-level course providing training on medical device regulatory submissions for approval that can help fill this unmet need...

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Bibliographic Details
Main Authors: Aaron E. Lottes, Andrew O. Brightman
Format: Article
Language:English
Published: Cambridge University Press 2021-03-01
Series:Journal of Clinical and Translational Science
Online Access:https://www.cambridge.org/core/product/identifier/S2059866121006749/type/journal_article