| Item/Criteria | Yes/No/N/A | Comments/Evidence |
|---|---|---|
| User needs and intended use are clearly defined and verified. | ||
| Design inputs are established and approved. | ||
| Risk analysis is performed and documented. | ||
| Design outputs are verified to match design inputs. | ||
| Validation was conducted under actual or simulated use conditions. | ||
| Clinical evaluation/clinical investigation completed (if applicable). | ||
| Labeling, packaging, and IFU reviewed and validated. | ||
| All validation protocols are approved and followed. | ||
| Traceability to requirements and risk controls confirmed. | ||
| Nonconformances documented and addressed. | ||
| All validation records retained and appropriately signed. |