Verify Versus Validate
Recall the practical difference between verification and validation in device development.
VV What are the two V questions? Which test belongs where? Both may be needed, but they answer different questions. All requirements passed, so validation is complete. A team tries to close the file after verification tests. Conformance to written inputs is being mistaken for intended-use evidence. Your line That closes verification. We still need evidence that intended users can use the device safely and effectively in the intended environment. It respects the different purpose of each evidence type without dismissing the completed test work. What is the fastest smell test for a validation plan? Look for representative users, realistic…
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