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019 ▼a 1021214462
020 ▼a 1785612492
020 ▼a 9781523115358
020 ▼a 1523115351
020 ▼a 9781785612497 ▼q (electronic bk.)
020 ▼z 1785612484
020 ▼z 9781785612480
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035 ▼a (OCoLC)1024286174 ▼z (OCoLC)1021214462
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1001 ▼a Coronato, Antonio, ▼d 1972- ▼e author.
24510 ▼a Engineering high quality medical software : ▼b regulations, standards, methodologies and tools for certification/ ▼c Antonio Coronato.
260 ▼a London, United Kingdom: ▼b The Institution of Engineering and Technology, ▼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
4901 ▼a Healthcare technologies series; ▼v 12
504 ▼a Includes bibliographical references (pages 267-270) and index.
5050 ▼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 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.
5058 ▼a 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.
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.
5880 ▼a Print version record.
590 ▼a Added to collection customer.56279.3 - Master record variable field(s) change: 072
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 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
650 7 ▼a HEALTH & FITNESS / Holism ▼2 bisacsh
650 7 ▼a HEALTH & FITNESS / Reference ▼2 bisacsh
650 7 ▼a MEDICAL / Alternative Medicine ▼2 bisacsh
650 7 ▼a MEDICAL / Atlases ▼2 bisacsh
650 7 ▼a MEDICAL / Essays ▼2 bisacsh
650 7 ▼a MEDICAL / Family & General Practice ▼2 bisacsh
650 7 ▼a MEDICAL / Holistic Medicine ▼2 bisacsh
650 7 ▼a MEDICAL / Osteopathy ▼2 bisacsh
655 4 ▼a Electronic books.
77608 ▼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.
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