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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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Detalles Bibliográficos
Autores principales: Lottes, Aaron E., Brightman, Andrew O.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8828017/
http://dx.doi.org/10.1017/cts.2021.674