ENGLISH

Safety Evaluation in the Development of Medical Devices and Combination Products

By C. Gad Shayne , Marian G. McCord

Book information

Publisher
Informa Healthcare
Year
2008
ISBN
1-4200-7164-5, 978-1-4200-7164-1
LCC
R857.M3 G33 2008
Open Library ID
OL11817252M
Language
english
Format
PDF
Filesize
9 MB (9381997 bytes)
Edition
3rd ed
Pages
314\314
Topic
Medicine
Library
Kingdwarf
Time added
2010-01-07 06:59:20

Description

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

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