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

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자료유형E-Book
개인저자Coronato, Antonio, 1972-, author.
서명/저자사항Engineering high quality medical software :regulations, standards, methodologies and tools for certification /Antonio Coronato.
발행사항London, United Kingdom : The Institution of Engineering and Technology, 2018.
형태사항1 online resource (xiii, 280 pages) : illustrations.
총서사항Healthcare technologies series ;12
소장본 주기Added to collection customer.56279.3 - Master record variable field(s) change: 072
ISBN1785612492
9781523115358
1523115351
9781785612497


서지주기Includes bibliographical references (pages 267-270) and index.
내용주기Intro; 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 devicesa?#x80;#x94;quality management systemsa?#x80;#x94;requirements for regulatory purposes; 6. ISO 14971: medical devicesa?#x80;#x94;application of risk management to medical devices; 7. IEC 62304: medical device softwarea?#x80;#x94;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 testing11. 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.
요약This 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.
일반주제명Medicine -- Computer programs.
Medicine -- Data processing.
Medical care -- Information technology.
Medical informatics.
Medical informatics.
Medicine -- Computer programs.
Medicine -- Data processing.
certification.
medical computing.
software quality.
standards.
HEALTH & FITNESS / Holism
HEALTH & FITNESS / Reference
MEDICAL / Alternative Medicine
MEDICAL / Atlases
MEDICAL / Essays
MEDICAL / Family & General Practice
MEDICAL / Holistic Medicine
MEDICAL / Osteopathy
언어영어
기타형태 저록Print version:Coronato, Antonio, 1972-Engineering high quality medical software.London, United Kingdom : The Institution of Engineering and Technology, 20181785612484
대출바로가기http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=1691712

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