Overview

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.

Full Product Details

Author:   Antonio Coronato (Researcher, Institute for High Performance Computing and Networking, National Research Council, Naples, Italy)
Publisher:   Institution of Engineering and Technology
Imprint:   Institution of Engineering and Technology
ISBN:  

9781785612480

ISBN 10:   1785612484
Pages:   296
Publication Date:   29 March 2018
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table 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

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Author Information

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.

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