V&V Overview (IVDR)

This page summarises product verification & validation topics commonly expected in IVDR technical documentation. Detailed checklists are in the child pages.

Mandatory interfaces

• [ ] V&V scope covers claimed performance and applicable GSPRs
• [ ] Traceability to risk-management hazards/controls
• [ ] Consistency with IFU / performance-evaluation claims
• [ ] Qualification of critical outsourced testing

Child pages

• Stability (reagents)
• Metrological traceability
• Usability / human factors
• Chemical / physical / biological
• Software & cybersecurity