Introduction to Medical Software: Foundations for Digital Health, Devices, and D

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ISBN
9781316514993
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Product Identifiers

Publisher
Cambridge University Press
ISBN-10
1316514994
ISBN-13
9781316514993
eBay Product ID (ePID)
7057265316

Product Key Features

Number of Pages
350 Pages
Publication Name
Introduction to Medical Software : Foundations for Digital Health, Devices, and Diagnostics
Language
English
Subject
Engineering (General), General
Publication Year
2022
Features
New Edition
Type
Textbook
Author
Ayesha N. Quraishi, Gregory P. Licholai, Xenophon Papademetris
Subject Area
Technology & Engineering, Medical
Series
Cambridge Texts in Biomedical Engineering Ser.
Format
Hardcover

Dimensions

Item Height
0.9 in
Item Length
9.9 in
Item Width
7.6 in

Additional Product Features

LCCN
2022-000137
Dewey Edition
23
Illustrated
Yes
Dewey Decimal
610.285
Edition Description
New Edition
Table Of Content
Preface; Part 1. Regulatory, Business and Management Background: 1. Introduction to medical software; 2. The FDA and software; 3. Operating within a healthcare system; 4. Quality management systems; 5. Risk management; 6. Taking an idea to market: understanding the product journey; 7. Medical software applications and growth drivers; Part II. Scientific and Technical Background: 8. Mathematical background; 9. Topics in software engineering; Part III. An Example Medical Software Life Cycle Process: 10. The overall process; 11. Identifying user needs; 12. The system requirements specification; 13. The software design document; 14. Software construction and testing and verification; 15. Software validation; 16. Deployment, maintenance and decommissioning; Part IV. Case Studies: 17. Therac-25: software that killed; 18. Mars Climate Orbiter: lost without a trace; 19. Healthcare.gov: the failed launch of a critical webpage; 20. The 2020 Iowa Caucus app: an unreliable app that caused national embarrassment; 21. The Boeing 737-MAX disasters: using software to fix hardware problems; 22. The averted Y2K crisis: successful crisis and risk management; References; Index.
Synopsis
Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process ; accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs., An overview of medical software design, implementation and management. Covers technical, commercial and regulatory issues and includes cautionary real-world case studies. For undergraduates in biomedical engineering, electrical engineering, computer science, junior software engineers in the medical device industry, and digital health entrepreneurs., Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process; accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs.
LC Classification Number
R855.3

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