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

Description

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. Abstract: 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.  Read more... 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.