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Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products (Fourth Edition)

Edited by Jack Wong, Edited by Raymond Tong

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normal price: R 10 166.95

Price: R 9 149.95

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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. The updated fourth edition includes specific contributions that address the needs of startups.

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The Memory Collectors: A Novel

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Paperback / softback
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The Colonialist: The Vision of Cecil Rhodes

William Kelleher Storey
Paperback / softback
528 pages
was: R 425.95
now: R 382.95
Usually dispatched in 6-12 days

This first comprehensive biography of Cecil Rhodes in a generation illuminates Rhodesâ€™s vision for the expansion of imperialism in southern Africa, connecting politics and industry to internal development, and examines how this fueled a lasting, white-dominated colonial society.

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Survive the AI Apocalypse: A guide for solutionists

Bronwen Williams
Paperback / softback
232 pages
was: R 340.95
now: R 306.95
Forthcoming

Let's stare the future down and, instead of fearing AI, become solutionists.

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The Coming Wave: AI, Power and Our Future

Mustafa Suleyman
Paperback / softback
352 pages
was: R 295.95
now: R 265.95
Stock is usually dispatched in 6-12 days from date of order

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