Guidance On Design Dossier Examination And Report

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Guidance on Design-Dossier Examination and Report …

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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

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Guidance for manufacturers and Notified Bodies on ...

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Guidance for manufacturers and Notified Bodies on reporting ... Document assessment related to the product or complete re-assessment of the design dossier or the type examination dossier Document assessment related to the quality system, special audit or complete re- ... The manufacturer must report to the Notified Body any plan of ...

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

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[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 …

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Guidance On Design Dossier Examination And Report