Engineering High Quality Medical Software - Regulations, standards, methodologies and tools for certification

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.

List of 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
  
  
  
  
  
  
  

  About the author

  
  
  
  
  
  
  
  
  
  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.
  
  
  

  Summary

  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.

Product details

• Authors: Antonio Coronato, Antonio (Researcher Coronato
• Publisher: Institution of Engineering and Technology
• Languages: English
• Product format: Hardback
• Released: 31.03.2018
• EAN: 9781785612480
• ISBN: 978-1-78561-248-0
• No. of pages: 296
• Dimensions: 244 mm x 166 mm x 22 mm
• Weight: 588 g
• Series: Healthcare Technologies; Healthcare Technologies
• Subject: Natural sciences, medicine, IT, technology > Technology > Chemical engineering