Medical-device case study
Nyxoah
Verification and validation for an implantable sleep-apnea neurostimulator: unit and integration tests to full coverage, dead-code analysis, and the reports an FDA and CE submission needs.
- 100% line & decision coverage
- Dead-code analysis
- FDA & CE submission reports
The device
Nyxoah’s Genio system is a battery-free implant that treats obstructive sleep apnea by stimulating the hypoglossal nerve, controlled from an external activation chip the patient wears at night. For a device implanted in the body, the software has to be verified to a standard a regulator will accept. Novodes built the test suite and the submission evidence to prove it.
What we built
A verification and validation effort built for regulatory submission: tests that prove the software, coverage that leaves no gaps, and reports that document every result.
Unit testing to full coverage
- Unit tests to 100% line coverage and 100% decision (branch) coverage.
- Full input-parameter coverage: every input parameter of every function exercised in a meaningful way, not just to hit the line.
- Written with the Cantata test tool, in C and C++.
Integration testing
- Integration tests covering several of the device’s major requirements.
- Each test traced back to the requirement it verifies.
Dead-code analysis
- Dead code identified across the codebase, then either removed or justified.
- Every justification captured in a dedicated report for the submission file.
Submission reports & tooling
- Unit-test report on a client-tailored template for FDA and CE submission, covering every single test: the test, its objective and its outcome.
- Integration-test report for FDA submission: each test, its objective, its outcome, and full traceability to the requirements.
- Report-generation tools we built in C# and Python to produce and update the reports quickly and consistently.
Technologies & tools
Need verification a regulator will accept? Let’s talk.
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