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25 Remote Warehouse Health and Medicine- Medical Specialties

In Vitro Diagnostic Medical Devices: Law and Practice in Five Eu Member States

by Whaite

In Vitro Diagnostic Medical Devices: Law and Practice in Five Eu Member States Cover

Synopses & Reviews

Publisher Comments:

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.

Book News Annotation:

A guide for in vitro diagnostic medical device manufacturers who are interested in selling their products in Europe, providing a systematic comparison of the laws regarding the development, production, distribution, and use of such devices within the five states. The coverage is both very specific and selective, including the general features of the national requirements, different product classes, placing devices on the market, the conformity of business operations, distribution to the patient or user, and post-marketing control. Based on a report requested by the European Commission. No index.
Annotation c. Book News, Inc., Portland, OR (booknews.com)

Product Details

ISBN:
9780792329961
Subtitle:
Law and Practice in Five Eu Member States
Other:
Maassen, Bernhard
Editor:
Maassen, B.
Author:
Whaite, Robin
Author:
Whaite
Publisher:
Springer Netherlands
Location:
Dordrecht ;
Subject:
Civil Procedure
Subject:
Prenatal care
Subject:
Biotechnology
Subject:
Prenatal diagnosis
Subject:
Diagnostic equipment industry.
Subject:
Prenatal diagnosis -- European Economic Community countries.
Subject:
Laboratory Medicine
Subject:
Medical Law & Legislation
Subject:
Prenatal care -- Law and legislation.
Series Volume:
91-19
Publication Date:
January 1994
Binding:
Hardcover
Language:
English
Illustrations:
Yes
Pages:
117
Dimensions:
9.21x6.14x.38 in. .82 lbs.

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