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CATEGORY: QUALITY SYSTEMS
Design Validation
Confirmation that the device meets user needs and intended uses under actual or simulated use conditions. Validation answers "Did we build the right product?" — typically through clinical evaluations and simulated use testing.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Validation confirms that devices meet user needs and intended uses (“did we build the right device?”). Includes design validation, process validation, software validation, and sterilization validation as applicable.
PROCESS / STEPS
- Define intended use and user needs as validation reference points.
- Select methods: simulated use, clinical evaluation, process PQ, software system testing.
- Use production-equivalent units under expected conditions.
- Document residual risks and limitations of validation evidence.
EXAMPLES
- Software system tests against user workflows and clinical validation of diagnostic accuracy are both validation activities.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Design Validation across 27 authorities in real time.
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