Engineering high quality medical software : regulations, standards, methodologies and tools for certification
This book focuses on high-confidence medical software in the growing field of e-health, telecare services and health technology. It covers the development of methodologies and engineering tasks together with standards and regulations for medical software.
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| Main Author | |
|---|---|
| Format | Electronic eBook |
| Language | English |
| Published |
London, United Kingdom :
The Institution of Engineering and Technology,
2018.
|
| Series | IET healthcare technologies series ;
12. |
| Subjects | |
| Online Access | Full text |
| ISBN | 9781523115358 1523115351 9781785612497 1785612492 9781785612480 1785612484 |
| Physical Description | 1 online resource (xiii, 280 pages) : illustrations |
Cover
Table of Contents:
- Intro
- Contents
- List of Acronyms
- Preface
- Part I. Introduction
- 1. Introduction
- Part II. Regulations
- 2. EU MDD 93/42/EEC
- 3. FDA title 21 of US CFR
- 4. Regulations for other markets
- Part III. Standards
- 5. ISO 13485: medical devices-quality management systems-requirements for regulatory purposes
- 6. ISO 14971: medical devices-application of risk management to medical devices
- 7. IEC 62304: medical device software-software life-cycle processes
- 8. IEEE 1012 and ISO/IEC 29119: standards for software verification
- Part IV. Verification and validation techniques
- 9. Static testing
- 10. Dynamic testing
- 11. Formal verification
- Part V. Techniques, methodologies, and engineering tasks for the development, configuration, and maintenance
- 12. Prescriptive software development life cycles
- 13. Agile software development life cycles
- 14. Project management
- 15. Risk management
- 16. Requirements management
- 17. Design controls and development management
- 18. Test management and defect management
- 19. Change management, configuration management, and change management
- Part VI. Conclusions
- 20. Conclusions
- References
- Index.