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Herausgegeben von Maassen, Bernhard M. Whaite, R.:

In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States - pocketboek

2010, ISBN: 9789048144396

[ED: Softcover], [PU: Springer Netherlands], Preface by T. Morrison, Director-General of the European Diagnostic Manufacturers Association. Contributors: W. Kewenig G. Forlani, J. Marria… Meer...

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In vitro Diagnostic Medical Devices:

Law and Practice in Five EU Member States - pocketboek

2010, ISBN: 9789048144396

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Erscheinungsdatum: 01.12.2010, Medium: Taschenbuch, Einband: Kartoniert / Broschiert, Titel: In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States, Auflage: Softc… Meer...

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Bernhard M. Maassen:
In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States - pocketboek

ISBN: 9789048144396

Paperback, [PU: Springer], This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available., … Meer...

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In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States - pocketboek

ISBN: 9048144396

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In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States ab 138.99 EURO Softcover reprint of hardcover 1st ed. 1994 Medien > Bücher

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In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States - Bernhard M. Maassen; R. Whaite
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Bernhard M. Maassen; R. Whaite:
In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States - pocketboek

2010, ISBN: 9789048144396

Buch, Softcover, Softcover reprint of hardcover 1st ed. 1994, [PU: Springer], Springer, 2010

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In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States
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Titel:
ISBN:

9789048144396


Preface by T. Morrison, Director-General of the European Diagnostic Manufacturers Association. Contributors: W. Kewenig; G. Forlani, J. Marriage, G. Ulloa This book is based upon a report prepared at the request of the European Commission. Its purpose is to set out the existing laws regulating the development, production, distribution and use of in vitro diagnostic medical devices (IVDMD) in the U.K., Germany, France, Italy and Spain. Each national section has the same structure and covers the same ground in order to enable comparisons. IVDM Devices includes not only reagents, but also technical instruments, or combination of both, for human use. The book is directed towards industry and the regulation is covered with a high degree of specificity. This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available. It is also the most convenient means of comparing those laws. As such, it will be a useful guide to all IVDM Devices manufacturers interested in the European market.

Gedetalleerde informatie over het boek. - In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States


EAN (ISBN-13): 9789048144396
ISBN (ISBN-10): 9048144396
Gebonden uitgave
pocket book
Verschijningsjaar: 2010
Uitgever: Springer
132 Bladzijden
Gewicht: 0,211 kg
Taal: eng/Englisch

Boek bevindt zich in het datenbestand sinds 2011-06-22T00:31:31+02:00 (Amsterdam)
Detailpagina laatst gewijzigd op 2023-03-02T22:41:16+01:00 (Amsterdam)
ISBN/EAN: 9789048144396

ISBN - alternatieve schrijfwijzen:
90-481-4439-6, 978-90-481-4439-6
alternatieve schrijfwijzen en verwante zoekwoorden:
Auteur van het boek: von maassen, maaßen, maass, whaites, bernhard
Titel van het boek: vitro, member

Gegevens van de uitgever

Auteur: Bernhard M. Maassen; R. Whaite
Titel: In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States
Uitgeverij: Springer; Springer Netherland
118 Bladzijden
Verschijningsjaar: 2010-12-01
Dordrecht; NL
Gedrukt / Gemaakt in
Gewicht: 0,454 kg
Taal: Engels
106,99 € (DE)
109,99 € (AT)
118,00 CHF (CH)
POD
XIV, 118 p.

BC; Medical Law; Hardcover, Softcover / Recht/Sonstiges; Recht des Gesundheitswesens und Medizinrecht; Verstehen; English; European Union (EU); Germany; Commercial Law; Laboratory Medicine; Public International Law; Medical Law; Commercial Law; Biomedical Research; Public International Law; Handelsrecht; Medizinische Forschung; Internationales Öffentliches Recht und Völkerrecht; BB

Preface; T. Morrison, Director-General of the European Diagnostic Manufacturers Association. Five Separate Chapters on In vitro Diagnostic Medical Devices (IVDMD) in the U.K., France, Germany, Italy and Spain, including: 1. General Features of National Regulation. 2. Different Product Classes and their Definitions: Underlying Rationale for Separate Legal Treatment. 3. Substantive Requirements Relating to the Placing of IVDMDs on the Market. 4. The Procedures Relating to the Establishment of the Conformity of IVDMD Business Operations and of IVDMDs against Operation-Related and/or Product-Related Requirements, Taking Existing Product Classes into Account. 5. Requirements Relating to the Distribution of IVDMDs to the Patient/User, Taking Existing Product Classes into Account. 6. Post-Marketing Control. Chapter 6: Summary of Findings of the National Reports.
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