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portada Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products
Type
Physical Book
Illustrated by
Publisher
Author
Language
English
Pages
766
Format
Hardcover
Dimensions
22.9 x 15.2 x 4.3 cm
Weight
1.24 kg.
ISBN13
9789814877862
Edition No.
0003
Categories

Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products

Jack Wong (Illustrated by) · Raymond Tong (Illustrated by) · Jenny Stanford Publishing · Hardcover

Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products - Wong, Jack ; Tong, Raymond

Physical Book

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Synopsis "Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products"

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

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