Peer-Reviewed Journal Details
Mandatory Fields
Masterson, F,Cormican, K
2013
November
Therapeutic Innovation & Regulatory Science
Overview of the Regulation of Medical Devices and Drugs in the European Union and the United States
Published
()
Optional Fields
medical device regulation drug regulation EU and US regulatory frameworks regulatory agencies
47
715
722
This article provides an overview of the regulation of medical devices and drugs in the European Union and the US. It is important for all stakeholders involved in bringing a medical device or drugs to market to have an understanding of the regulatory requirements involved in this process. This article demonstrates that the regulation of these products is an extremely complex process.
DOI 10.1177/2168479013500969
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