Sign-In
Cart
Engineering Reliable Medical Device Software: Patient Safety, Lifecycle Evidence, and Engineering Practice in the AI Era
Paperback
Technology & EngineeringProgramming
Publisher: Independently Published
Published: Aug 4 2026
Pages: 470
Weight: 2.38
Height: 0.95 Width: 8.50 Depth: 11.00
Language: English
Engineering Reliable Medical Device Software is a practical guide to building software that must protect patients, support clinicians, and remain dependable throughout the full medical-device lifecycle.
Written from the perspective of an engineer with more than two decades of experience in medical imaging and regulated product development, the book explains why medical-device software reliability cannot be reduced to defect counts, uptime percentages, or a final verification campaign. Reliability begins with intended use and patient harm, then continues through requirements, architecture, risk control, testing, release, installation, service, cybersecurity, and post-market learning.
The book shows how to:
- Define reliability goals that engineers can measure and defend.
- Build operational profiles that reflect real clinical workflows, rare high-risk conditions, degraded environments, and field variation.
- Apply software FMEA, fault-tree analysis, reliability modeling, observability, fault management, combinatorial testing, reliability-growth testing, and reliability-demonstration testing.
- Design for safe degradation, recovery, redundancy, maintainability, and diagnostic evidence.
- Control SOUP, third-party dependencies, cybersecurity risks, software updates, configuration drift, and fielded versions.
- Evaluate AI-enabled medical software, including model performance, input quality, human interaction, monitoring, fallback behavior, and controlled change.
- Use AI-assisted engineering tools without allowing generated code, tests, trace links, or risk analyses to become unverified evidence.
- Connect engineering decisions to IEC 62304, ISO 14971, usability engineering, FDA expectations, quality management systems, and post-market obligations.
The book includes formulas, worked examples, milestone reviews, practical templates, review questions, glossary definitions, and lessons from real medical-device failures.
It is written for software engineers, systems engineers, reliability engineers, technical leaders, quality and regulatory professionals, and anyone responsible for deciding whether medical-device software is ready to be trusted in real clinical use.
Also in
Programming
Interactive Theorem Proving and Program Development: Coq'art: The Calculus of Inductive Constructions
Castéran, Pierre
Bertot, Yves
Hardcover
The Legend of Zelda(tm) Tears of the Kingdom - The Complete Official Guide: Collector's Edition
Piggyback
Hardcover
Python Crash Course, 3rd Edition: A Hands-On, Project-Based Introduction to Programming
Matthes, Eric
Paperback
Accelerate: The Science of Lean Software and DevOps: Building and Scaling High Performing Technology Organizations
Humble, Jez
Kim, Gene
Forsgren Phd, Nicole
Paperback
The Legend of Zelda(tm) Tears of the Kingdom - The Complete Official Guide: Standard Edition
Piggyback
Paperback
Crisis Engineering: Time-Tested Tools for Turning Chaos Into Clarity
Nitze, Marina
Weaver, Matthew
Dickerson, Mikey
Paperback
Embedded Systems with ARM Cortex-M Microcontrollers in Assembly Language and C: Fourth Edition
Zhu, Yifeng
Paperback
Fundamentals of Software Architecture: A Modern Engineering Approach
Richards, Mark
Ford, Neal
Paperback
Vibe Coding: Building Production-Grade Software with Genai, Chat, Agents, and Beyond
Yegge, Steve
Kim, Gene
Paperback
Make: Electronics: Learning by Discovery: A Hands-On Primer for the New Electronics Enthusiast
Platt, Charles
Paperback
AI Projects with Raspberry Pi: High-Performance Artificial Intelligence for Robotics, Security, Home Automation, and Vision
Jepson, Brian
Hattersley, Lucy
Paperback
The Manager's Path: A Guide for Tech Leaders Navigating Growth and Change
Fournier, Camille
Paperback
I Have an App Idea: The Essential Guide to Building an App Without Tech Skills
Spann, Amanda
Paperback
The Return on AI: From Promise to Profit in the Age of Intelligent Business
Sawhney, Mohanbir
Mittal, Ashwin
Paperback
The Devops Handbook, 2nd Edition: How to Create World-Class Agility, Reliability, & Security in Technology Organizations
Debois, Patrick
Kim, Gene
Humble, Jez
Paperback
Building Applications with AI Agents: Designing and Implementing Multiagent Systems
Albada, Michael
Paperback
The Developer's Guide to AI: A Field Guide for the Working Developer
Reghunadh, Jerry M.
Thompson, Danny
Orshalick, Jacob
Paperback
The Staff Engineer's Path: A Guide for Individual Contributors Navigating Growth and Change
Reilly, Tanya
Paperback
Cracking the Coding Interview: 189 Programming Questions and Solutions
McDowell, Gayle Laakmann
Paperback
Software Architecture: The Hard Parts: Modern Trade-Off Analyses for Distributed Architectures
Richards, Mark
Sadalage, Pramod
Ford, Neal
Paperback
Learning Web Design: A Beginner's Guide to Html, Css, Javascript, and Web Images
Robbins, Jennifer
Paperback
The New AI Cold War: Liberty vs. Tyranny in the Age of Machine Empires
Maginnis, Ltc Robert L.
Paperback
Observability Engineering: Achieving Production Excellence
Miranda, George
Majors, Charity
Fong-Jones, Liz
Paperback
Forecasting: Principles and Practice, the Pythonic Way
Hyndman, Rob J.
Athanasopoulos, George
Paperback
Building Safer Technology: A Field Guide to Failing Well
Kissner, Lea
Zunger, Yonatan
Coles, Neil
Paperback
SQL QuickStart Guide: The Simplified Beginner's Guide to Managing, Analyzing, and Manipulating Data With SQL
Shields, Walter
Hardcover
The Pragmatic Programmer: Your Journey to Mastery, 20th Anniversary Edition
Hunt, Andrew
Thomas, David
Hardcover
Linux Basics for Hackers, 2nd Edition: Getting Started with Networking, Scripting, and Security in Kali
Occupytheweb
Paperback
Grokking Algorithms, Second Edition: An Illustrated Guide for Programmers and Other Curious People
Bhargava, Aditya Y.
Paperback
Generative AI Design Patterns: Solutions to Common Challenges When Building Genai Agents and Applications
Lakshmanan, Valliappa
Hapke, Hannes
Paperback
The Official Raspberry Pi Handbook 2026: Astounding Projects with Raspberry Pi Computers
Makers of Raspberry Pi Official Magazine, The
Paperback
Concrete Mathematics: A Foundation for Computer Science
Knuth, Donald
Graham, Ronald
Patashnik, Oren
Hardcover
Head First Design Patterns: Building Extensible and Maintainable Object-Oriented Software
Freeman, Eric
Robson, Elisabeth
Paperback
Learning Domain-Driven Design: Aligning Software Architecture and Business Strategy
Khononov, Vlad
Paperback
Arduino Programming for Beginners: A Comprehensive Beginner's Guide to Learn the Realms of Arduino Programming from A-Z
Protosmith, Ada
Paperback
The Software Architect Elevator: Redefining the Architect's Role in the Digital Enterprise
Hohpe, Gregor
Paperback
Frictionless: 7 Steps to Remove Barriers, Unlock Value, and Outpace Your Competition in the AI Era
Forsgren, Nicole
Noda, Abi
Paperback
Learning Generative AI Tools for Excel: Speed Up Your Everyday Tasks with Microsoft Excel, Copilot, Chatgpt, and Beyond
Duca, Angelica Lo
Paperback
Building AI-Powered Products: The Essential Guide to AI and Genai Product Management
Nika, Marily
Paperback
Debugging: The 9 Indispensable Rules for Finding Even the Most Elusive Software and Hardware Problems
Agans, David J.
Paperback
A Human's Guide to Machine Intelligence: How Algorithms Are Shaping Our Lives and How We Can Stay in Control
Hosanagar, Kartik
Paperback
Build an AI Agent (from Scratch): Agents That Reason, Plan, and ACT Autonomously
Hur, Jungjun
Song, Younghee
Paperback
Learning Php, MySQL & JavaScript: A Step-By-Step Guide to Creating Dynamic Websites
Nixon, Robin
Paperback
Software Engineering at Google: Lessons Learned from Programming Over Time
Winters, Titus
Manshreck, Tom
Wright, Hyrum
Paperback
Living a Jewish Life, Revised and Updated: Jewish Traditions, Customs, and Values for Today's Families
Cooper, Howard
Diamant, Anita
Paperback
Python Programming for Young Coders: A Hands-On, Project-Based Introduction to Coding for Beginners, Kids, and Teens
Pandey, Anand
Paperback
Computer Science from Scratch: Building Interpreters, Art, Emulators and ML in Python
Kopec, David
Paperback
Adobe Photoshop, 2nd Edition: A Complete Course and Compendium of Features
Laskevitch, Stephen
Paperback
Programming Massively Parallel Processors: A Hands-On Approach
El Hajj, Izzat
Hwu, Wen-Mei W.
Kirk, David B.
Paperback
Signals & Levers: Systems Thinking Tools to Unblock Software Delivery
Hendrickson, Elisabeth
Tosi, Joel
Paperback
Kubernetes in Action, Second Edition: Deploying and Managing Containers and Cloud-Native Applications
Luksa, Marko
Conner, Kevin
Paperback
Articulating Design Decisions: Communicate with Stakeholders, Keep Your Sanity, and Deliver the Best User Experience
Greever, Tom
Paperback
Embedded Systems with ARM Cortex-M Microcontrollers in Assembly Language and C: Third Edition
Zhu, Yifeng
Paperback
Prompt Engineering for Llms: The Art and Science of Building Large Language Model-Based Applications
Berryman, John
Ziegler, Albert
Paperback
Pro C# 10 with .Net 6: Foundational Principles and Practices in Programming
Troelsen, Andrew
Japikse, Phil
Paperback