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Medical Device Regulation
A Comparative Analysis of Medical Device Regulation in the EU and the USA
Taschenbuch von Ann-Marie Jahn
Sprache: Englisch

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Beschreibung
This thesis analyses the regulation of medical devices in the United States of America and in the European Union. It covers the principles of health economics and fundamental aspects of the regulation of medical devices in both trade regions. It will focus on the legal framework and the different approaches used to secure patient health and safety. The role of EU Member States and the European Commission as competent authorities in the EU and the FDA as a governmental body in the US is explained. Case studies from both regimes will demonstrate failures and changes for the regulation of medical devices are proposed at the end of the thesis.
This thesis analyses the regulation of medical devices in the United States of America and in the European Union. It covers the principles of health economics and fundamental aspects of the regulation of medical devices in both trade regions. It will focus on the legal framework and the different approaches used to secure patient health and safety. The role of EU Member States and the European Commission as competent authorities in the EU and the FDA as a governmental body in the US is explained. Case studies from both regimes will demonstrate failures and changes for the regulation of medical devices are proposed at the end of the thesis.
Über den Autor
holds a Bachelor's degree in International Business from Berlin School of Economics and Law and Anglia Ruskin University Cambridge. She has worked for Siemens Healthcare USA in the field of IT Project Management and for Siemens Energy Germany in Business Development for Turbomachinery. Currently, she is a Master student at Warwick University.
Details
Erscheinungsjahr: 2012
Fachbereich: Einzelne Wirtschaftszweige
Genre: Recht, Sozialwissenschaften, Wirtschaft
Rubrik: Recht & Wirtschaft
Medium: Taschenbuch
Inhalt: 84 S.
ISBN-13: 9783639446050
ISBN-10: 3639446054
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Jahn, Ann-Marie
Hersteller: AV Akademikerverlag
Verantwortliche Person für die EU: OmniScriptum GmbH & Co. KG, Bahnhofstr. 28, D-66111 Saarbrücken, info@akademikerverlag.de
Maße: 220 x 150 x 6 mm
Von/Mit: Ann-Marie Jahn
Erscheinungsdatum: 21.08.2012
Gewicht: 0,143 kg
Artikel-ID: 106316479
Über den Autor
holds a Bachelor's degree in International Business from Berlin School of Economics and Law and Anglia Ruskin University Cambridge. She has worked for Siemens Healthcare USA in the field of IT Project Management and for Siemens Energy Germany in Business Development for Turbomachinery. Currently, she is a Master student at Warwick University.
Details
Erscheinungsjahr: 2012
Fachbereich: Einzelne Wirtschaftszweige
Genre: Recht, Sozialwissenschaften, Wirtschaft
Rubrik: Recht & Wirtschaft
Medium: Taschenbuch
Inhalt: 84 S.
ISBN-13: 9783639446050
ISBN-10: 3639446054
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Jahn, Ann-Marie
Hersteller: AV Akademikerverlag
Verantwortliche Person für die EU: OmniScriptum GmbH & Co. KG, Bahnhofstr. 28, D-66111 Saarbrücken, info@akademikerverlag.de
Maße: 220 x 150 x 6 mm
Von/Mit: Ann-Marie Jahn
Erscheinungsdatum: 21.08.2012
Gewicht: 0,143 kg
Artikel-ID: 106316479
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