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How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

BACKGROUND: Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these...

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Detalles Bibliográficos
Autores principales: Kramer, Daniel B., Xu, Shuai, Kesselheim, Aaron S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3418047/
https://www.ncbi.nlm.nih.gov/pubmed/22912563
http://dx.doi.org/10.1371/journal.pmed.1001276