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

GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A …

GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A …

meddev.info

10.1 Examination of design dossier 20 ... • how to document a clinical evaluation in a clinical evaluation report. The guidance contained within this document is intended to apply to medical devices ... NBOG BPG 2009-1 Guidance on design dossier examination and report content

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

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

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