Main description:

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.

Contents:

Part I: Introduction

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