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Medical Device Regulatory Practices: An International Perspective by Val Theisz (Hardcover, 2015)

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Product Information

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators' language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Product Identifiers

Publisher
Pan Stanford Publishing Pte Ltd
ISBN-13
9789814669108
eBay Product ID (ePID)
214378368

Product Key Features

Author
Val Theisz
Publication Name
Medical Device Regulatory Practices: an International Perspective
Format
Hardcover
Language
English
Subject
Medicine, Engineering & Technology, Healthcare System
Publication Year
2015
Type
Textbook
Number of Pages
590 Pages

Dimensions

Item Height
229mm
Item Width
152mm
Item Weight
930g

Additional Product Features

Title_Author
Val Theisz
Country/Region of Manufacture
Singapore

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Medical Device Regulatory Practices: An International Perspective by Val Theisz (Hardcover, 2015)

About this product

Product Information

Product Identifiers

Product Key Features

Dimensions

Additional Product Features

Best Selling in Adult Learning & University

Australian Native Bee Book: Keeping Stingless Bee Hives for Pets, Pollination and Sugarbag Honey by Tim Heard (Paperback, 2015)

The Weed Forager's Handbook: A Guide to Edible and Medicinal Weeds in Australia by Adam Grubb, Annie Raser-Rowland (2012, Paperback)

Permaculture: A Designer's Manual by Bill Mollison (Hardcover, 1988)

The Falsification of History: Our Distorted Reality by John Hamer (Paperback, 2013)

In-Basket Case Studies by Guy Adamson (Paperback, 1986)

Empire of the Summer Moon: Quanah Parker and the Rise and Fall of the Comanches, the Most Powerful Indian Tribe in American History by S.C. Gwynne (Paperback, 2011)

Botanical Field Guide by Stefan Mager (Fold-out book or chart, 2021)

Save on Adult Learning & University

Netter Atlas of Human Anatomy: Classic Regional Approach

Havard's Nursing Guide to Drugs

Steven Holzner Physics Essentials For Dummies (Paperback)

T. Jared Bunch Matthew LaPlante John D. Day The AFib Cure (Paperback)

Care of People with Diabetes: A Manual for Healthcare Practice

The Fourth Turning By Neil Howe, William Strauss

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