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Search results with tag "Guidance on design dossier examination and report"

Guidance on Design-Dossier Examination and Report …

Guidance on Design-Dossier Examination and Report

www.doks.nbog.eu

Guidance on Design-Dossier Examination and Report Content 1 Background The objective of this document is to give guidance to: – the Notified Bodies (NB) of the type of content expected of the Notified Body Design Dossier Reports of Medical Device manufacturers to ensure manufacturer’s confor-mance to the relevant Directive

  Design, Report, Guidance, Dossiers, Content, Examination, Guidance on design dossier examination and report, Design dossier, Guidance on design dossier examination and report content

Guidance on Notified Body‘s Tasks of Technical ...

Guidance on Notified Body‘s Tasks of Technical ...

www.doks.nbog.eu

[4] NBOG BPG 2009-1 Guidance on Design-Dossier Examination and Report Content [5] EN ISO 15225 : 2000/A1 : 2004 Nomenclature – Specification for a nomenclature system for medical devices for the purpose of regula-tory data exchange [6] NBOG BPG 2009-3 NBOG Guidance

  Design, Report, Guidance, Dossiers, Examination, Guidance on design dossier examination and report

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