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Research Article

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

  • Daniel B. Kramer mail,

    dkramer@bidmc.harvard.edu

    Affiliations: Harvard Medical School, Boston, Massachusetts, United States of America, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America

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  • Shuai Xu,

    Affiliation: Harvard Medical School, Boston, Massachusetts, United States of America

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  • Aaron S. Kesselheim

    Affiliations: Harvard Medical School, Boston, Massachusetts, United States of America, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America

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  • Published: July 31, 2012
  • DOI: 10.1371/journal.pmed.1001276

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