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BL
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| Record Number
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852695
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| Main Entry
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Coronato, Antonio,1972-
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| Title & Author
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Engineering high quality medical software : : regulations, standards, methodologies and tools for certification /\ Antonio Coronato.
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| Publication Statement
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London, United Kingdom :: The Institution of Engineering and Technology,, 2018.
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, ©2018
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| Series Statement
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Healthcare technologies series ;; 12
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| Page. NO
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1 online resource (xiii, 280 pages) :: illustrations
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| ISBN
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1523115351
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: 1785612492
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: 9781523115358
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: 9781785612497
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1785612484
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9781785612480
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| Bibliographies/Indexes
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Includes bibliographical references (pages 267-270) and index.
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| Contents
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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.
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| Abstract
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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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| Subject
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Medical care-- Information technology.
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Medical informatics.
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Medicine-- Computer programs.
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Medicine-- Data processing.
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certification.
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HEALTH FITNESS-- Holism.
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HEALTH FITNESS-- Reference.
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medical computing.
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Medical informatics.
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MEDICAL-- Alternative Medicine.
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MEDICAL-- Atlases.
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MEDICAL-- Essays.
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MEDICAL-- Family General Practice.
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MEDICAL-- Holistic Medicine.
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MEDICAL-- Osteopathy.
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Medicine-- Computer programs.
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Medicine-- Data processing.
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software quality.
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standards.
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Medical Informatics-- standards.
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Software Design.
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Computing Methodologies.
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| Dewey Classification
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610.285
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| LC Classification
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R858.C67 2018eb
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| NLM classification
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2019 A-324
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W 26.55.S6
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