Which items are typical checks in software verification for medical device software?

• A. Only unit tests, with no other checks.
• B. Unit tests, integration tests, hardware-in-the-loop tests, code reviews, static/dynamic analysis, and traceability to requirements.
• C. Hardware-in-the-loop tests only.
• D. Static analysis and dynamic analysis only.

Answer: (B)

In medical device software, verification requires a broad, layered approach to show safety and effectiveness. Unit tests verify that individual components behave correctly in isolation. Integration tests check that combined modules interact properly and data flows as intended. Hardware-in-the-loop tests bring in real hardware or realistic simulators to validate timing, communication, and control behavior under real-world conditions. Code reviews catch defects, improve quality, and enhance maintainability. Static analysis examines the code without execution to flag potential defects, while dynamic analysis observes the program during execution to catch runtime issues. Finally, tracing verification activities to requirements ensures every requirement is addressed and supports regulatory audits.

That combination covers the full spectrum of verification needs, which is why it’s the best answer. Relying on only one type (for example, just unit tests or just hardware-in-the-loop) misses essential checks and regulatory expectations.