World Conference Calendar

32784 Conferences

Construct and Manage the Technical File and Design Dossier

Added by Referral on 2010-08-12

Conference Dates:

Start Date Start Date: 2010-08-19
Last Date Last Day: 2010-08-19

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This CE technical files based training Webinar will discuss the difference between Technical File and Design Dossier and explain how to create them and the best practices.

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 companyspecific 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.

For More Details:
http://bit.ly/auRX5S
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