Areas Covered in the Seminar:

• Learn the differences between the Tech File and Dossier and why the construction phase is so important.


• Compile the EU Technical File or Design Dossier and ensure Format and Content expectations are addressed appropriately.


• Understand why Design Dossier is viewed as a subset of the Tech Documentation with emphasis on “design”.


• Determine exactly which materials need to be assembled.


• NB must examine the application for examination of the design dossier and, if the product conforms to the relevant provisions of the Directive, issue the application with an EC design-dossier certificate.


• Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s).


• Determine applicable standards and address company-specific SOPs for constructing and managing your files.


• European Norms and Standards and other documents supporting Technical Files and Design Dossiers.


• Guidance on Design-Dossier Examination and Report Content.

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