Matches in SemOpenAlex for { <https://semopenalex.org/work/W2904631610> ?p ?o ?g. }
Showing items 1 to 80 of
80
with 100 items per page.
- W2904631610 endingPage "372" @default.
- W2904631610 startingPage "361" @default.
- W2904631610 abstract "In the event of design changes in a medical device, the same pathway for approval as the initial released product must be obtained from the authority in accordance with country-specific regulations. In this paper, we collect materials on the change management of medical devices approved by the US Food and Drug Administration (FDA) and analyze the design change data sets from the viewpoint of a digital X-ray device. Based on this analysis, we investigate the association among the items that need a 510(k) to be cleared, and then present a model for assessing the impact of 510(k) clearance on the basis of the related items. From this model, two key contributing causes for decision of change permission are derived, expressing as membership function graphs. Moreover, we will develop a fuzzy-based expert system that predicts the degree of the change registration of an X-ray device through a deductive reasoning in advance for many design change ideas. Finally, we analyze the correlation between the evaluation result of non-experts using this system and the evaluation result depending on the experience of human experts according to FDA 510(k) guidance." @default.
- W2904631610 created "2018-12-22" @default.
- W2904631610 creator A5001591774 @default.
- W2904631610 creator A5013595401 @default.
- W2904631610 creator A5060517141 @default.
- W2904631610 date "2018-12-31" @default.
- W2904631610 modified "2023-09-25" @default.
- W2904631610 title "Development of a Registration-impact Assessment Model for the FDA 510(k) Clearance in Relation to Design Changes of an X-ray Device" @default.
- W2904631610 doi "https://doi.org/10.7315/cde.2018.361" @default.
- W2904631610 hasPublicationYear "2018" @default.
- W2904631610 type Work @default.
- W2904631610 sameAs 2904631610 @default.
- W2904631610 citedByCount "0" @default.
- W2904631610 crossrefType "journal-article" @default.
- W2904631610 hasAuthorship W2904631610A5001591774 @default.
- W2904631610 hasAuthorship W2904631610A5013595401 @default.
- W2904631610 hasAuthorship W2904631610A5060517141 @default.
- W2904631610 hasConcept C112930515 @default.
- W2904631610 hasConcept C124101348 @default.
- W2904631610 hasConcept C126894567 @default.
- W2904631610 hasConcept C138944611 @default.
- W2904631610 hasConcept C14036430 @default.
- W2904631610 hasConcept C154945302 @default.
- W2904631610 hasConcept C17744445 @default.
- W2904631610 hasConcept C199539241 @default.
- W2904631610 hasConcept C2524010 @default.
- W2904631610 hasConcept C25343380 @default.
- W2904631610 hasConcept C2779089604 @default.
- W2904631610 hasConcept C3018890749 @default.
- W2904631610 hasConcept C33923547 @default.
- W2904631610 hasConcept C41008148 @default.
- W2904631610 hasConcept C42475967 @default.
- W2904631610 hasConcept C44154836 @default.
- W2904631610 hasConcept C58166 @default.
- W2904631610 hasConcept C71924100 @default.
- W2904631610 hasConcept C78458016 @default.
- W2904631610 hasConcept C86803240 @default.
- W2904631610 hasConcept C90673727 @default.
- W2904631610 hasConceptScore W2904631610C112930515 @default.
- W2904631610 hasConceptScore W2904631610C124101348 @default.
- W2904631610 hasConceptScore W2904631610C126894567 @default.
- W2904631610 hasConceptScore W2904631610C138944611 @default.
- W2904631610 hasConceptScore W2904631610C14036430 @default.
- W2904631610 hasConceptScore W2904631610C154945302 @default.
- W2904631610 hasConceptScore W2904631610C17744445 @default.
- W2904631610 hasConceptScore W2904631610C199539241 @default.
- W2904631610 hasConceptScore W2904631610C2524010 @default.
- W2904631610 hasConceptScore W2904631610C25343380 @default.
- W2904631610 hasConceptScore W2904631610C2779089604 @default.
- W2904631610 hasConceptScore W2904631610C3018890749 @default.
- W2904631610 hasConceptScore W2904631610C33923547 @default.
- W2904631610 hasConceptScore W2904631610C41008148 @default.
- W2904631610 hasConceptScore W2904631610C42475967 @default.
- W2904631610 hasConceptScore W2904631610C44154836 @default.
- W2904631610 hasConceptScore W2904631610C58166 @default.
- W2904631610 hasConceptScore W2904631610C71924100 @default.
- W2904631610 hasConceptScore W2904631610C78458016 @default.
- W2904631610 hasConceptScore W2904631610C86803240 @default.
- W2904631610 hasConceptScore W2904631610C90673727 @default.
- W2904631610 hasIssue "4" @default.
- W2904631610 hasLocation W29046316101 @default.
- W2904631610 hasOpenAccess W2904631610 @default.
- W2904631610 hasPrimaryLocation W29046316101 @default.
- W2904631610 hasRelatedWork W11631426 @default.
- W2904631610 hasRelatedWork W1493159477 @default.
- W2904631610 hasRelatedWork W1971038572 @default.
- W2904631610 hasRelatedWork W1996705673 @default.
- W2904631610 hasRelatedWork W3111174684 @default.
- W2904631610 hasRelatedWork W3154633948 @default.
- W2904631610 hasRelatedWork W3154953863 @default.
- W2904631610 hasRelatedWork W3197972770 @default.
- W2904631610 hasRelatedWork W4238426114 @default.
- W2904631610 hasRelatedWork W4297215919 @default.
- W2904631610 hasVolume "23" @default.
- W2904631610 isParatext "false" @default.
- W2904631610 isRetracted "false" @default.
- W2904631610 magId "2904631610" @default.
- W2904631610 workType "article" @default.