دانلود کتاب Engineering high quality medical software: regulations, standards, methodologies and tools for certification

فهرست مطالب :

Content: 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.