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