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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| Main Author | |
|---|---|
| Format | Electronic eBook |
| Language | English |
| Published |
London, United Kingdom :
The Institution of Engineering and Technology,
2018.
|
| Series | IET healthcare technologies series ;
12. |
| Subjects | |
| Online Access | Full text |
| ISBN | 9781523115358 1523115351 9781785612497 1785612492 9781785612480 1785612484 |
| Physical Description | 1 online resource (xiii, 280 pages) : illustrations |
Cover
| LEADER | 00000cam a2200000 i 4500 | ||
|---|---|---|---|
| 001 | kn-on1024286174 | ||
| 003 | OCoLC | ||
| 005 | 20240717213016.0 | ||
| 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 |