A Beginners Road Map to the Medical Device Industry
eBook - PDF

A Beginners Road Map to the Medical Device Industry

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  1. 291 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

A Beginners Road Map to the Medical Device Industry

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About this book

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.

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Yes, you can access A Beginners Road Map to the Medical Device Industry by in PDF and/or ePUB format. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Arcler Press
Year
2022
eBook ISBN
9781774693353
Edition
0
Topic
Law
Index
Law

Table of contents

  1. Cover
  2. Title Page
  3. Copyright
  4. ABOUT THE AUTHOR
  5. TABLE OF CONTENTS
  6. List of Figures
  7. List of Tables
  8. List of Boxes
  9. List of Abbreviations
  10. Preface
  11. Chapter 1 Introduction
  12. Chapter 2 Effect of Global Trends on Medical Device Demands
  13. Chapter 3 A Brief History of Medical Device Regulations
  14. Chapter 4 What Is a Medical Device?
  15. Chapter 5 Manufacturing a Medical Device
  16. Chapter 6 How Do We Ensure Safety of Medical Devices?
  17. Chapter 7 Regulating Medical Devices
  18. Chapter 8 How Can a Manufacturer Ensure Compliance?
  19. Chapter 9 How to Classify a Medical Device?
  20. Chapter 10 Understanding the Summary Technical Documentation (STED)
  21. Bibliography
  22. Index
  23. Back Cover