Engineering Reliable Medical Device Software

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.