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Engineering high quality medical software : regulations, standards, methodologies and tools for certification
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| 자료유형 | 단행본 |
|---|---|
| 서명/저자사항 | Engineering high quality medical software : regulations, standards, methodologies and tools for certification/ Antonio Coronato. |
| 개인저자 | Coronato, Antonio,1972- author. |
| 발행사항 | London, United Kingdom: The Institution of Engineering and Technology, 2018. |
| 형태사항 | 1 online resource (xiii, 280 pages): illustrations. |
| 총서사항 | Healthcare technologies series;12 |
| 기타형태 저록 | Print version: Coronato, Antonio, 1972- Engineering high quality medical software. London, United Kingdom : The Institution of Engineering and Technology, 2018 1785612484 |
| ISBN | 1785612492 9781523115358 1523115351 9781785612497 |
| 서지주기 | Includes bibliographical references (pages 267-270) and index. |
| 내용주기 | 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. 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. |
| 요약 | 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. |
| 일반주제명 | Medicine --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 |
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