Overview of the regulation of medical devices and drugs in the European Union and the United States
| dc.contributor.author | Masterson, Fiona | |
| dc.contributor.author | Corcoran, Kathryn | |
| dc.date.accessioned | 2016-11-25T09:31:15Z | |
| dc.date.available | 2016-11-25T09:31:15Z | |
| dc.date.issued | 2013-08-06 | |
| dc.identifier.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 | en_IE |
| dc.identifier.issn | 2164-9200 | |
| dc.identifier.uri | http://hdl.handle.net/10379/6175 | |
| dc.description.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. | en_IE |
| dc.description.sponsorship | This work was funded by a Fellowship in the College of Engineering and Informatics, National University of Ireland, Galway, Ireland. | en_IE |
| dc.format | application/pdf | en_IE |
| dc.language.iso | en | en_IE |
| dc.publisher | SAGE Publications | en_IE |
| dc.relation.ispartof | Therapeutic Innovation & Regulatory Science | en |
| dc.subject | Medical device regulation | en_IE |
| dc.subject | Drug regulation | en_IE |
| dc.subject | EU regulatory frameworks | en_IE |
| dc.subject | US regulatory frameworks | en_IE |
| dc.subject | Regulatory agencies | en_IE |
| dc.title | Overview of the regulation of medical devices and drugs in the European Union and the United States | en_IE |
| dc.type | Article | en_IE |
| dc.date.updated | 2016-11-23T13:32:33Z | |
| dc.identifier.doi | 10.1177/2168479013500969 | |
| dc.local.publishedsource | http:/dx.doi.org/10.1177/2168479013500969 | en_IE |
| dc.description.peer-reviewed | peer-reviewed | |
| dc.contributor.funder | |~| | |
| dc.internal.rssid | 5645674 | |
| dc.local.contact | Kathryn Cormican, Mechanical & Biomedical Eng, Eng-2046, New Engineering Building, Nui Galway. 3975 Email: kathryn.cormican@nuigalway.ie | |
| dc.local.copyrightchecked | No | |
| dc.local.version | SUBMITTED | |
| nui.item.downloads | 969 |
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