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Engineering high quality medical software : regulations, standards, methodologies and tools for certification

Author: Antonio Coronato
Publisher: London, United Kingdom : The Institution of Engineering and Technology, 2018. ©2018
Series: IET healthcare technologies series, 12.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
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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Genre/Form: Electronic books
Additional Physical Format: Print version:
Coronato, Antonio, 1972-
Engineering high quality medical software.
London, United Kingdom : The Institution of Engineering and Technology, 2018
(OCoLC)999551590
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Antonio Coronato
ISBN: 9781523115358 1523115351 9781785612497 1785612492
OCLC Number: 1024286174
Description: 1 online resource (xiii, 280 pages) : illustrations.
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.
Series Title: IET healthcare technologies series, 12.
Responsibility: Antonio Coronato.

Abstract:

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  Read more...

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