Design verification

Verification answers 'did we build the device right?' — bench testing, dimensional checks, electrical safety, biocompatibility, software unit/integration testing, all traced back to design inputs. Validation answers 'did we build the right device?' — typically simulated-use or clinical evaluation with representative users and use environments, including human-factors validation (IEC 62366).

The traceability matrix linking user need → design input → design output → verification test → validation evidence is the single artefact auditors most rely on to navigate a DHF.