Overview of the Regulation of Medical Devices and Drugs in the European Union and the United States

Kathryn Cormican

doi:http://hdl.handle.net/10379/6175

Overview of the Regulation of Medical Devices and Drugs in the European Union and the United States

Kathryn Cormican

Mechanical Engineering

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

8 Citations (Scopus)

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.

Original language	English (Ireland)
Number of pages	8
Journal	Therapeutic Innovation & Regulatory Science
Volume	47
DOIs	https://doi.org/http://hdl.handle.net/10379/6175
Publication status	Published - 1 Nov 2013

Authors (Note for portal: view the doc link for the full list of authors)

Authors
Masterson, F,Cormican, K

Access to Document

http://hdl.handle.net/10379/6175

Cite this

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