Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations
eBook - ePub

Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations

  1. 290 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations

About this book

This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house.

It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations.

This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice.

Key Features:

  • Up to date with the latest regulations in the UK, the EU, and the US
  • Useful for those producing medical software for routine clinical use
  • Contains best practice

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Yes, you can access Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by Philip S. Cosgriff,Matthew J. Memmott in PDF and/or ePUB format, as well as other popular books in Medicine & Computer Science General. We have over one million books available in our catalogue for you to explore.

Information

Table of contents

  1. Cover
  2. Half Title
  3. Title Page
  4. Copyright Page
  5. Dedication
  6. Table of Contents
  7. Preface
  8. Acknowledgements
  9. Chapter 1 Introduction
  10. Chapter 2 The Need for In-House Development of Medical Software
  11. Chapter 3 Types of Health Software
  12. Chapter 4 Basic Concepts of Risk and Safety
  13. Chapter 5 Standards and Guidelines
  14. Chapter 6 Regulation of Medical Devices
  15. Chapter 7 Best Practice and Legal Liability
  16. Chapter 8 Security of Medical Devices
  17. Chapter 9 Future Regulation of Medical Device Software
  18. Chapter 10 Summary
  19. Index