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.
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.
Antonio Coronato is a researcher at the Institute for High Performance Computing and Networking at the National Research Council in Naples, Italy. He is Co-Editor in Chief of the Journal of Reliable Intelligent Environments and Technical Associate Editor of the IEEE Computer Communication Magazine. He is an ISTQB certified software tester.
Inhaltsangabe
1. Part I: Introduction * Chapter 1: Introduction 2. Part II: Regulations * Chapter 2: EU MDD 93/42/EEC * Chapter 3: FDA title 21 of US CFR * Chapter 4: Regulations for other markets 3. Part III: Standards * Chapter 5: ISO 13485: medical devices - quality management systems- requirements for regulatory purposes * Chapter 6: ISO 14971: medical devices - application of risk management to medical devices * Chapter 7: IEC 52304: medical device software - software life-cycle processes * Chapter 8: IEEE 1012 and ISO/IEC 29119: standards for software verification 4. Part IV: Verification and validation techniques * Chapter 9: Static testing * Chapter 10: Dynamic testing * Chapter 11: Formal verification 5. Part V: Techniques, methodologies, and engineering tasks for the development, configuration and maintenance * Chapter 12: Prescriptive software development life cycles * Chapter 13: Agile software development life cycles * Chapter 14: Project management * Chapter 15: Risk management * Chapter 16: Requirements management * Chapter 17: Design controls and development management * Chapter 18: Test management and defect management * Chapter 19: Change management, configuration management and change management 6. Part VI: Conclusions * Chapter 20: Conclusions
