Design Change Validation Inadequate

Preferred Label : Design Change Validation Inadequate;

Alternative definition : FDA: Problems traced to inadequate or lack of validation of design changes of the device leading to malfunction or unintended properties of the device including possible hazards for persons using the device.;

NCI Metathesaurus CUI : CL526869;

Codes from synonyms : 4306;

Details

Origin ID

C139476;

UMLS CUI

C4528501;

Semantic type(s)
- Functional Concept [UMLS semantic type]
concept_is_in_subset
- CDRH Cause Investigation - Investigation Conclusion Terminology [NCIt concept]
- FDA Center For Devices and Radiological Health Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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