Construct and Manage the Technical File and Design Dossier
Venue: Online Event
|Event Date/Time: Jul 12, 2010||End Date/Time: Jul 12, 2010|
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 â€œdesignâ€.
- 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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