The Medical Device Handbook For Europe
eBook - PDF

The Medical Device Handbook For Europe

  1. 367 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

The Medical Device Handbook For Europe

Book details
Table of contents
Citations

About This Book

As the medical device landscape continues to evolve, so does the regulatory framework in Europe. Through this process many gaps and scarcity of skills and expertise have also been identified. For this reason, there was an increasing need to update the current medical device directive (MDD 93/42/EEC) being used within the European Union. This in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). The release of the new Medical Device Regulation (EU MDR 2017/745) in 2017 marked the start of a three-year transition period for various Economic Operators along the supply chain. This volume aims to provide a simple overview of the medical device industry in Europe with particular focus on the main aspects covered in the new European Medical Device Regulation. Important concepts such as essential phases in a device lifecycle, complying to standards and regulations, the CE mark process and classification of medical devices in Europe are covered.

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Yes, you can access The Medical Device Handbook For Europe by Shalinee Naidoo in PDF and/or ePUB format, as well as other popular books in Medicine & Internal Medicine & Diagnosis. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Arcler Press
Year
2023
ISBN
9781774696842
Topic
Medicine
Subtopic
Internal Medicine & Diagnosis

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 to Medical Devices
  12. Chapter 2 Introduction to the Medical Device Market
  13. Chapter 3 Developing a Medical Device
  14. Chapter 4 Standards and Regulations
  15. Chapter 5 Regulating Medical Devices
  16. Chapter 6 Regulating Medical Devices in Europe
  17. Chapter 7 The Medical Device Directive (MDD 93/42/EEC)
  18. Chapter 8 Transitioning From the MDD to the MDR
  19. Chapter 9 Classification of Medical Devices in Europe
  20. Chapter 10 Safety and Performance of Medical Devices
  21. Chapter 11 Biocompatibility Testing
  22. Chapter 12 Easy Review Questions Around Biocompatibility Testing
  23. Chapter 13 Economic Operators
  24. Chapter 14 Person Responsible for Regulatory Compliance
  25. Bibliography
  26. Index
  27. Back Cover