Regulation of Medical Devices in the United States and European Union
Abstract
As compared with Europe, the United States generally requires more rigorous clinical testing of high-risk devices, which delays patients' access to new devices but may provide better assurance of device...
Paper Details
Title
Regulation of Medical Devices in the United States and European Union
Published Date
Mar 1, 2012
Volume
366
Issue
9
Pages
848 - 855
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