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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Elsevier
2017
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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 |