Construct and Manage the Technical File and Design Dossier

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jul 12, 2010 End Date/Time: Jul 12, 2010
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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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