Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification (Healthcare Technologies) - Hardcover

Coronato, Antonio

Hardcover

ISBN 10: 1785612484 ISBN 13: 9781785612480

Publisher: The Institution of Engineering and Technology, 2018

Synopsis

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.

About this title

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.

Edition details

• Publisher: The Institution of Engineering and Technology
• Publication date: 2018
• Language: English
• ISBN 10: 1785612484
• ISBN 13: 9781785612480
• Binding: Hardcover
• Edition number: 1
• Number of pages: 296