
Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations
- 290 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
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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Information
Table of contents
- Cover
- Half Title
- Title Page
- Copyright Page
- Dedication
- Table of Contents
- Preface
- Acknowledgements
- Chapter 1 Introduction
- Chapter 2 The Need for In-House Development of Medical Software
- Chapter 3 Types of Health Software
- Chapter 4 Basic Concepts of Risk and Safety
- Chapter 5 Standards and Guidelines
- Chapter 6 Regulation of Medical Devices
- Chapter 7 Best Practice and Legal Liability
- Chapter 8 Security of Medical Devices
- Chapter 9 Future Regulation of Medical Device Software
- Chapter 10 Summary
- Index