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

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  • Book title: Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification

  • Author:

  • Year: 2018

  • Format: Hardback

  • Product Code: PBHE0120

  • ISBN: 978-1-78561-248-0

  • Pagination: 296pp

  • Stock Status: Pre-order

    The arrival date is January 2018
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This one-stop reference 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. Key topics covered include configuration, design, verification and validation, risk management, testing and maintenance. This book is written for research-focused engineers, scientists and practitioners who focus on healthcare software and e-health platforms and technologies.

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.

Book readership

This book is essential reading for research-focused engineers, scientists and practitioners in academia, industry and medical settings who focus on healthcare software and e-health platform and technologies; designers, engineers and producers of medical software; small and medium enterprises involved in the production, integration or maintenance of medical software and platforms; healthcare and technology consultants and professionals active in the medical software field; institutional end users, university lecturers and students in the field; and stakeholders, standard and public authorities.

Book contents

This information is provisional and will be updated prior to publication

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 Lifecycle Processes
Chapter 8: IEEE 1012 and ISO/IEC 29119: Standards for software verification
Part IV: Verification & Validation Techniques
Chapter 9: Static Testing
Chapter 10: Dynamic Testing
Chapter 11: Formal Verification
Part V: Techniques, Methodologies and Engineering Tasks for 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

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