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BestsellerE-book
Author Coronato, Antonio, 1972- author.

Title Engineering high quality medical software : regulations, standards, methodologies and tools for certification / Antonio Coronato.

Publication Info. London, United Kingdom : The Institution of Engineering and Technology, 2018.
©2018

Item Status

Description 1 online resource (xiii, 280 pages) : illustrations.
Physical Medium polychrome
Description text file
Series Healthcare technologies series ; 12
IET healthcare technologies series ; 12.
Bibliography Includes bibliographical references (pages 267-270) and index.
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.
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.
Local Note eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America
Subject Medicine -- Computer programs.
Medicine -- Computer programs.
Medicine.
Medicine -- Data processing.
Medicine -- Data processing.
Medical care -- Information technology.
Medical care.
Information technology.
Medical informatics.
Medical informatics.
Genre/Form Electronic books.
Subject Medical care.
Other Form: Print version: Coronato, Antonio, 1972- Engineering high quality medical software. London, United Kingdom : The Institution of Engineering and Technology, 2018 1785612484 (OCoLC)999551590
ISBN 9781523115358
1523115351
9781785612497 (electronic book)
1785612492 (electronic book)
9781785612480
1785612484