Matches in DBpedia 2016-04 for { <http://dbpedia.org/resource/Independent_reviewer> ?p ?o }
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- Independent_reviewer abstract "The US Food and Drug Administration requires that developers of medical device follow a system of design controls. A key part of this system is design review, defined in 21CFR820.3 section (h) as \"a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.\"In 21CFR820.30 section (e), it is stated that an independent reviewer is required for any design review. An independent reviewer is an individual who does not have direct professional responsibility for the design stage under review, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the design may overlook design errors. Thus, reviewers should not have been significantly involved in the activities under review.".
- Independent_reviewer wikiPageExternalLink CFRSearch.cfm?fr=820.3.
- Independent_reviewer wikiPageExternalLink CFRSearch.cfm?fr=820.30.
- Independent_reviewer wikiPageID "26342748".
- Independent_reviewer wikiPageLength "1381".
- Independent_reviewer wikiPageOutDegree "11".
- Independent_reviewer wikiPageRevisionID "422701378".
- Independent_reviewer wikiPageWikiLink Category:Food_and_Drug_Administration.
- Independent_reviewer wikiPageWikiLink Design.
- Independent_reviewer wikiPageWikiLink Design_controls.
- Independent_reviewer wikiPageWikiLink Evaluation.
- Independent_reviewer wikiPageWikiLink Food_and_Drug_Administration.
- Independent_reviewer wikiPageWikiLink Medical_device.
- Independent_reviewer wikiPageWikiLink Overlook.
- Independent_reviewer wikiPageWikiLink Professional_responsibility.
- Independent_reviewer wikiPageWikiLink Requirement.
- Independent_reviewer wikiPageWikiLink Review.
- Independent_reviewer wikiPageWikiLinkText "independent reviewer".
- Independent_reviewer wikiPageUsesTemplate Template:Unreferenced.
- Independent_reviewer subject Category:Food_and_Drug_Administration.
- Independent_reviewer type Drug.
- Independent_reviewer type Agency.
- Independent_reviewer type Drug.
- Independent_reviewer comment "The US Food and Drug Administration requires that developers of medical device follow a system of design controls.".
- Independent_reviewer label "Independent reviewer".
- Independent_reviewer sameAs Q6017538.
- Independent_reviewer sameAs m.0bbycjp.
- Independent_reviewer sameAs Q6017538.
- Independent_reviewer wasDerivedFrom Independent_reviewer?oldid=422701378.
- Independent_reviewer isPrimaryTopicOf Independent_reviewer.