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A New Model for European Medical Device Regulation : a comparative legal analysis in the EU and the USA.
Edité par
Europa Law Pub Netherlands, 2003
ISBN 10 : 9076871183
ISBN 13 : 9789076871189
Ancien ou d'occasion
Couverture rigide
Vendeur : Kloof Booksellers & Scientia Verlag, Amsterdam, Pays-Bas
Évaluation du vendeur 4 sur 5 étoiles
Etat : very good. Groningen: Europa Law Publishing, 2003. Orig. hardback, 311 pp. Thesis. - This book analyses the regulation of medical devices at the federal level in the United States and in the European Union. It covers fundamental aspects (substantive and procedural) of the regulation of medical devices in both regimes, in order to assess the current European institutional framework. The author proposes regulatory reforms for the regulation of medical devices. It is suggested to create a new Community body, the European Medical Device Agency. The US Food and Drug Administration has served as a source of inspiration. This book gives answers to the question why a European Medical Device Agency is needed, its legal implications and its competences and structure (including how to organise all relevant parties concerned). It is proposed that the European Medical Device Agency should have a central role in the regulation of medical devices throughout the European Union. Condition : very good copy. ISBN 9789076871189. Keywords : RECHT, *2006-100 medisch recht. N° de réf. du vendeur 176071
Acheter D'occasion
EUR 26,95
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Expédition depuis Pays-Bas vers Etats-Unis
Expédition depuis Pays-Bas vers Etats-Unis
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