In the name of of Allah the Merciful

دانلود کتاب امور نظارتی پزشکی: کتاب راهنمای بین ‌المللی برای دستگاه‌ های پزشکی و محصولات بهداشتی، ویرایش سوم

Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products, 3rd Edition | Jack Wong, Raymond K. Y. Tong | ISBN: 9814877867, 978-9814877862, 9789814877862, B09MR4LDL7

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سال انتشار: 2022

تعداد صفحات: 806

زبان فایل: انگلیسی

فرمت فایل: PDF

حجم فایل: 39MB

ناشر: Jenny Stanford Publishing

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, and academics and students will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.