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£80 today · previous high £80 · all-time low £78

Arcler Press A Simple Guide to Understanding Medical Device Regulations

Amazon

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£80.32 £77.45 £78.08 £78.70 £79.33 £79.95 £80.58 26 July 2026 14 August 2026 02 September 2026 21 September 2026 10 October 2026
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Price range: £78 - £80

Price levels: 3 different prices over 77 days

Description
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.

Product Specifications
Brand
Arcler Press
Format
hardcover
ASIN
1774076284
Category
Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners
Domain
Amazon UK
Release Date
30 November 2020
Listed Since
10 September 2020

Barcode

No barcode data available

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