Automated Testing in CI/CD
Purpose
Define how to automate tests (unit, integration, system/HIL where feasible) in CI/CD pipelines for medical devices with gating and evidence capture.
When to Apply
- •Setting up or updating test stages in CI/CD.
Requirements (testable)
- •Scope: Include unit, integration, and where possible system/HIL or simulators; prioritize safety-related modules. Rationale: coverage of risk areas.
- •Gating: Fail pipeline on test failures; no ignored failures for safety code. Rationale: prevent regressions.
- •Artifacts: Store test results (JUnit/XML), logs, coverage, and evidence; retain per release. Rationale: auditability.
- •Flake Management: Detect and address flaky tests; quarantine with issue filed and timeline; do not ignore. Rationale: trustworthiness.
- •Hardware Tests: If hardware required, provide conditional stages and fallbacks (sim); schedule regular hardware runs (nightly). Rationale: practicality with coverage.
Recommended Practices
- •Tag tests by type/priority; run critical ones on every commit.
- •Use retries sparingly and only for known flaky, with tracking.
- •Parallelize to keep feedback fast.
- •Use containerized or pinned environments.
Patterns
CI job snippet:
yaml
test:
script: [ "ctest --output-on-failure" ]
artifacts:
when: always
paths: [ "build/test-results.xml", "coverage/" ]
Flake tracking entry:
yaml
test_id: TEST-INT-210 status: flaky issue: QA-1234 expires: 2026-02-01
Anti-Patterns (risks)
- •Allowing tests to fail without blocking or tracking -> risk: regressions.
- •No artifacts/logs retained -> risk: unverifiable results.
- •Silent retries masking real failures -> risk: shipping defects.
Verification Checklist
- • Unit/integration (and sim/HIL if available) tests run in CI.
- • Failures gate merges; no ignored failures for safety code.
- • Results/logs/coverage stored as artifacts per run/release.
- • Flaky tests tracked with issues and timelines.
- • Hardware-dependent tests scheduled; sim fallback provided.
Traceability
- •Link CI test runs to test IDs (
TEST-###) and requirements; store artifacts with release metadata.
References
- •IEC 62304 verification expectations.
- •FDA/MDR submission evidence needs.
Changelog
- •1.0.0 (2026-01-04): Initial automated testing skill with gating and artifact capture.
Audit History
- •2026-01-04: Audit performed. Verified:
- •IEC 62304 verification expectations correctly referenced
- •CI/CD patterns follow industry best practices for regulated environments