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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.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Coronato, Antonio, 1972- (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London, United Kingdom : The Institution of Engineering and Technology, 2018.
Colección:IET healthcare technologies series ; 12.
Temas:
Acceso en línea:Texto completo

MARC

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100 1 |a Coronato, Antonio,  |d 1972-  |e author. 
245 1 0 |a Engineering high quality medical software :  |b regulations, standards, methodologies and tools for certification /  |c Antonio Coronato. 
264 1 |a London, United Kingdom :  |b The Institution of Engineering and Technology,  |c 2018. 
264 4 |c ©2018 
300 |a 1 online resource (xiii, 280 pages) :  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a Healthcare technologies series ;  |v 12 
588 0 |a Print version record. 
504 |a Includes bibliographical references (pages 267-270) and index. 
520 |a 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. 
505 0 |a 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. 
590 |a Knovel  |b ACADEMIC - Software Engineering 
650 0 |a Medicine  |x Computer programs. 
650 0 |a Medicine  |x Data processing. 
650 0 |a Medical care  |x Information technology. 
650 0 |a Medical informatics. 
650 1 2 |a Medical Informatics  |x standards 
650 1 2 |a Software Design 
650 2 2 |a Computing Methodologies 
650 6 |a Médecine  |x Logiciels. 
650 6 |a Médecine  |x Informatique. 
650 7 |a HEALTH & FITNESS  |x Holism.  |2 bisacsh 
650 7 |a HEALTH & FITNESS  |x Reference.  |2 bisacsh 
650 7 |a MEDICAL  |x Alternative Medicine.  |2 bisacsh 
650 7 |a MEDICAL  |x Atlases.  |2 bisacsh 
650 7 |a MEDICAL  |x Essays.  |2 bisacsh 
650 7 |a MEDICAL  |x Family & General Practice.  |2 bisacsh 
650 7 |a MEDICAL  |x Holistic Medicine.  |2 bisacsh 
650 7 |a MEDICAL  |x Osteopathy.  |2 bisacsh 
650 7 |a Medical informatics.  |2 fast  |0 (OCoLC)fst01014175 
650 7 |a Medicine  |x Computer programs.  |2 fast  |0 (OCoLC)fst01014919 
650 7 |a Medicine  |x Data processing.  |2 fast  |0 (OCoLC)fst01014924 
650 7 |a certification.  |2 inspect 
650 7 |a medical computing.  |2 inspect 
650 7 |a software quality.  |2 inspect 
650 7 |a standards.  |2 inspect 
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830 0 |a IET healthcare technologies series ;  |v 12. 
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