Medical Device Regulatory Practices

Medical Device Regulatory Practices An International Perspective

Hardback (10 Sep 2015)

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Publisher's Synopsis

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.

Book information

ISBN: 9789814669108
Publisher: Taylor & Francis
Imprint: Jenny Stanford Publishing
Pub date:
DEWEY: 610.28
DEWEY edition: 23
Language: English
Weight: 990g
Height: 160mm
Width: 236mm
Spine width: 39mm