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$189.50
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In Vitro Diagnostic Medical Devices: Law and Practice in Five Eu Member Statesby Whaite
Synopses & ReviewsPublisher 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) What Our Readers Are SayingBe the first to add a comment for a chance to win!Product Details
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