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A Simple Guide to Understanding Medical Device Regulations

Shalinee Naidoo (author)

ISBN: 9781774076286

Publication Date: Dec 2020

Format: Hardback

Provides an overview of how regulatory systems work and what goes into implementing a simple regulatory framework. The book also highlights the importance of long-lasting good governance where regulation of medical devices is concerned and provides a step-by-step approach on the development of national regulatory programs.
£152.00

Temporarily out of stock: usually despatched in 10-14 days

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As innovation and rapid advancement in technologies take over, medical devices have now become one of the fastest-growing industries globally. In 2000, it was estimated that one and half million different medical devices were available on the market worldwide. For many countries, their regulatory systems have proven to be ineffective in quality management and in monitoring the domestic market to prevent unsafe and low-quality medical products from entering. The lack of harmonized processes when assessing the safety and efficacy or performance of medical products has also led to an increase in costs associated with licensing where required. Regulatory controls for medical devices are often complicated to implement due to the many different types of devices available on the market. Often the risks associated with each type of device differ, making the opportunity for misuse considerable. The purpose of this book is to provide readers with an overview of how regulatory systems work and what goes into implementing a simple regulatory framework. It also aims to highlight the importance of long-lasting good governance where regulation of medical devices is concerned and to provide a step-by-step approach on the development of national regulatory programs for medical devices. It looks at what are some of the guiding principles and essential features of a simple medical device regulatory program, what governs the safety of medical devices and who is responsible for implementation, applying conformity assessment rules and the use of standards to guide a regulatory model.
Pages 277
Dimensions 229 x 152
Date Published 30 Dec 2020
Publisher Arcler Press
Subject/s Technology: general issues   Biochemical engineering   Medical equipment & techniques   Biotechnology   Instruments & instrumentation engineering  

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