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Overview of the regulation of medical devices and drugs in the European Union and the United States

Masterson, Fiona
; 
Corcoran, Kathryn
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Identifiers
http://hdl.handle.net/10379/6175
 https://doi.org/10.13025/19093
Publication Date
2013-08-06
Keywords
Medical device regulation, Drug regulation, EU regulatory frameworks, US regulatory frameworks, Regulatory agencies
Type
Article
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Citation
Masterson, F,Cormican, K (2013) 'Overview of the Regulation of Medical Devices and Drugs in the European Union and the United States'. Therapeutic Innovation & Regulatory Science, 47 :715-722. DOI 10.1177/2168479013500969
Abstract
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.
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|~|
Publisher
SAGE Publications
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Attribution-NonCommercial-NoDerivs 3.0 Ireland
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Collections
Mechanical Engineering (Scholarly Articles)