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In vitro Diagnostic Medical Devices
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In vitro Diagnostic Medical Devices

Softcover reprint of hardcover 1st ed. 1994

Book Details

Format Paperback / Softback
ISBN-10 9048144396
ISBN-13 9789048144396
Edition Softcover reprint of hardcover 1st ed. 1994
Publisher Springer
Imprint Springer
Country of Manufacture GB
Country of Publication GB
Publication Date Dec 1st, 2010
Print length 118 Pages
Ksh 16,200.00
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This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available.
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.

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