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Glossary Term
Design Validation
Definition
Design Validation is the process of confirming that a medical device meets user needs and intended use under actual or simulated conditions. It ensures that the final product fulfills its functional, clinical, and regulatory requirements before market release.
Relevance to the MedTech Industry
Design Validation ensures that medical devices are safe, effective, and aligned with end-user expectations. It is a critical step in the design controls process, providing evidence that the device performs as intended in real-world conditions.
Additional Information & Related Terms
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