Engineering High Quality 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.

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