No longer confined to medical devices, medical software has become a pervasive technology giving healthcare operators access to clinical information stored in electronic health records and clinical decision support systems, supporting robot-assisted telesurgery, and providing the technology behind ambient assisted living. These systems and software must be designed, built and maintained according to strict regulations and standards to ensure that they are safe, reliable and secure.
Engineering High Quality Medical Software illustrates how to exploit techniques, methodologies, development processes and existing standards to realize high-confidence medical software. After an introductory survey of the topic the book covers global regulations and standards (including EU MDD 93/42/EEC, FDA Title 21 of US CFR, ISO 13485, ISO 14971, IEC 52304, IEEE 1012 and ISO/IEC 29119), verification and validation techniques and techniques, and methodologies and engineering tasks for the development, configuration and maintenance of medical software.
- Chapter 1: Introduction
- Part II: Regulations
- Chapter 2: EU MDD 93/42/EEC
- Chapter 3: FDA title 21 of US CFR
- Chapter 4: Regulations for other markets
- 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
- Part IV: Verification and validation techniques
- Chapter 9: Static testing
- Chapter 10: Dynamic testing
- Chapter 11: Formal verification
- 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
- Part VI: Conclusions
- Chapter 20: Conclusions
Institute for High Performance Computing and Networking, National Research Council, Naples, Italy.
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.