Engineering Reliable Medical Device Software: Patient Safety, Lifecycle Evidence, and Engineering Practice in the AI Era

By Dr. Gang Cheng

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.

• Format: Paperback
• Language: English
• ISBN: B0HDB2CFB4
• ISBN13: 9798189973369
• Release Date: August 2026
• Publisher: Independently Published
• Length: 470 Pages
• Weight: 2.38 lbs.
• Dimensions: 0.9" x 8.5" x 11.0"