Textbook in PDF format

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.
Preface
Acknowledgments
Regulatory, Business, and Management Background
Introduction to Medical Software
The FDA and Software
Operating within a Healthcare System
Quality Management Systems
Risk Management
Taking an Idea to Market: Understanding the Product Journey
Medical Software Applications and Growth Drivers
Scientific and Technical Background
Mathematical Background
Topics in Software Engineering
An Example Medical Software Life Cycle Process
Identifying User Needs
Introduction
The System Requirements Specification
The Software Design Document
Software Construction, Testing, and Verification
Software Validation
Deployment, Maintenance, and Decommissioning
Case Studies
Therac-25: Software that Killed
Mars Climate Orbiter: Lost without a Trace
HealthCare.gov: The Failed Launch of a Critical Website
The 2020 Iowa Caucus App: An Unreliable App that CausedNational Embarrassment
The Boeing 737 MAX Disasters: Using Software to Fix Hardware Problems
The Averted Y2K Crisis: Successful Crisis and Risk Management
Index