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FDA, CE mark or something else?—Thinking fast and slow

There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own prob...

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Detalles Bibliográficos
Autor principal: Mishra, Sundeep
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5319122/
https://www.ncbi.nlm.nih.gov/pubmed/28228288
http://dx.doi.org/10.1016/j.ihj.2016.11.327