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Full Description
It is estimated that there are over 10 000 different medical devices available on the market today. These devices have become an integral part of health care and a vital component of the various activities carried out by health-care providers to treat people with varying medical conditions all around the world. Regulatory requirements for such devices differ from country to country all around the world which in turn make it difficult for manufacturers to obtain all round market approval for their products. While market approval from regulatory authorities can easily be obtained if a manufacturer can prove the device meets national regulatory guidelines; differences in regulatory requirements between different countries means that a manufacturer's registration process becomes more complex and ultimately may require additional resources or information. This volume aims to provide a basic roadmap to beginners into the medical device industry. It provides a simplistic overview of the vast history behind much of the regulations and medical technology governing the field today as well as the need and importance of associated medical device regulations and essential principles governing safe and effective manufacture and use of these devices.
Contents
Chapter 1 Introduction
Chapter 2 Effect of Global Trends on Medical Device Demands
Chapter 3 A Brief History of Medical Device Regulations
Chapter 4 What Is a Medical Device?
Chapter 5 Manufacturing a Medical Device
Chapter 6 How Do We Ensure Safety of Medical Devices?
Chapter 7 Regulating Medical Devices
Chapter 8 How Can a Manufacturer Ensure Compliance?
Chapter 9 How to Classify a Medical Device?
Chapter 10 Understanding the Summary Technical Documentation (STED)
