Verification and validation of your device

Verification shows the device meets its design requirements; validation shows it meets its users' needs in real use. Your technical file carries this as two documents, and your tracker shows one row for each:

Your expert authors both: the Plan lists each planned test with its method and acceptance criterion, and the Report records the outcome of each test with the controlled document that holds the evidence. You do not fill in test methods, criteria or outcomes anywhere — those never appear as questions on your side.

The one question you answer

The Plan asks you a single planning question, under "Information we need from you": who in your organisation performs, reviews and approves the verification and validation activities. Answer it like any other request. The Report asks you nothing at all.

Provide your test reports

1. Upload each test or verification report from your Documents page ("Add documents"), like any other file.
2. Declare it from the row's ⋯ menu ("Edit metadata") so it becomes a controlled document with a kind and a status.
3. Give it a kind your expert can cite as V&V evidence: "Verification or test report", "Manufacturer technical specification" or "Quality-system procedure or record". Only these three kinds can stand behind a recorded result — a document filed under another kind cannot be cited for one.
4. Keep the declaration current. If you supersede or retire a cited document, the evidence stops standing and your expert has to re-cite it before the Report can be re-issued.