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dc.contributor.authorMasterson, Fiona
dc.contributor.authorCorcoran, Kathryn
dc.date.accessioned2016-11-25T09:31:15Z
dc.date.available2016-11-25T09:31:15Z
dc.date.issued2013-08-06
dc.identifier.citationMasterson, 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 10.1177/2168479013500969en_IE
dc.identifier.issn2164-9200
dc.identifier.urihttp://hdl.handle.net/10379/6175
dc.description.abstractThis 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.sponsorshipThis work was funded by a Fellowship in the College of Engineering and Informatics, National University of Ireland, Galway, Ireland.en_IE
dc.formatapplication/pdfen_IE
dc.language.isoenen_IE
dc.publisherSAGE Publicationsen_IE
dc.relation.ispartofTherapeutic Innovation & Regulatory Scienceen
dc.subjectMedical device regulationen_IE
dc.subjectDrug regulationen_IE
dc.subjectEU regulatory frameworksen_IE
dc.subjectUS regulatory frameworksen_IE
dc.subjectRegulatory agenciesen_IE
dc.titleOverview of the regulation of medical devices and drugs in the European Union and the United Statesen_IE
dc.typeArticleen_IE
dc.date.updated2016-11-23T13:32:33Z
dc.identifier.doi10.1177/2168479013500969
dc.local.publishedsourcehttp:/dx.doi.org/10.1177/2168479013500969en_IE
dc.description.peer-reviewedpeer-reviewed
dc.contributor.funder|~|
dc.internal.rssid5645674
dc.local.contactKathryn Cormican, Mechanical & Biomedical Eng, Eng-2046, New Engineering Building, Nui Galway. 3975 Email: kathryn.cormican@nuigalway.ie
dc.local.copyrightcheckedNo
dc.local.versionSUBMITTED
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