Verification asks: did we build it correctly?
Verification demonstrates that specified design outputs satisfy the corresponding design inputs. It therefore depends on clear, testable and traceable requirements.
- Inspection and review
- Analysis and simulation
- Bench testing
- Software requirements-based testing
- Comparison with an approved reference
Validation asks: did we build the right product?
Validation demonstrates that the resulting device meets user needs and intended uses under actual or simulated use conditions. Production-equivalent units and representative users, environments and workflows are normally central to the argument.
Plan from the beginning
If teams wait until design completion to define acceptance criteria, samples, environments and methods, they often discover that requirements cannot be verified or user needs cannot be meaningfully validated.
Key takeaways
- Verification is anchored to design inputs; validation is anchored to user needs and intended use.
- Both require predetermined acceptance criteria.
- A credible evidence strategy develops alongside the design.
This article provides general educational information. Applicable requirements depend on the device, jurisdiction, lifecycle stage and current regulatory position.