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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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| Hauptverfasser: | , , |
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| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
Public Library of Science
2012
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| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3418047/ https://ncbi.nlm.nih.gov/pubmed/22912563 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1371/journal.pmed.1001276 |
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