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.

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Bibliographic Details
Main Author: Coronato, Antonio, 1972- (Author)
Format: eBook
Language: English
Published: London, United Kingdom : The Institution of Engineering and Technology, 2018.
Series: IET healthcare technologies series ; 12.
Subjects:
ISBN: 9781523115358
1523115351
9781785612497
1785612492
9781785612480
1785612484
Physical Description: 1 online resource (xiii, 280 pages) : illustrations

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Table of contents

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006 m o d
007 cr cn|||||||||
008 180224t20182018enka ob 001 0 eng d
040 |a EBLCP  |b eng  |e rda  |e pn  |c EBLCP  |d LGG  |d MERUC  |d YDX  |d KNOVL  |d OCLCQ  |d CDN  |d UIU  |d OCLCF  |d EZ9  |d OTZ  |d STF  |d OCLCQ  |d N$T  |d AU@  |d LVT  |d CUS  |d CUV  |d OCLCO  |d UKAHL  |d OCLCQ  |d OCLCA  |d K6U  |d OCLCA  |d UX1  |d OCLCO  |d OCLCQ  |d OCLCO  |d OSU  |d OCLCQ  |d OCLCO  |d OCLCL  |d BRX 
020 |a 9781523115358 
020 |a 1523115351 
020 |a 9781785612497  |q (electronic bk.) 
020 |a 1785612492  |q (electronic bk.) 
020 |z 9781785612480  |q (hardcover) 
020 |z 1785612484  |q (hardcover) 
035 |a (OCoLC)1024286174  |z (OCoLC)1021214462  |z (OCoLC)1057434301  |z (OCoLC)1058572820 
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 
504 |a Includes bibliographical references (pages 267-270) and index. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
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 Knovel (All titles) 
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. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
776 0 8 |i Print version:  |a Coronato, Antonio, 1972-  |t Engineering high quality medical software.  |d London, United Kingdom : The Institution of Engineering and Technology, 2018  |z 1785612484  |w (OCoLC)999551590 
830 0 |a IET healthcare technologies series ;  |v 12. 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpEHQMSRS1/engineering-high-quality?kpromoter=marc  |y Full text