Design Dossier definition

Design Dossier means the compilation of technical documentation per Council Directive 93/42/EEC as last amended, and related notices of change submitted to the notified body for conformity assessment and/or design examination of the Cordis PRECISE® Carotid Stent System or any aspect thereof.
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Examples of Design Dossier in a sentence

  • Any Letter of Authorization, Right of Access Letter or other information provided by Cordis under this subparagraph 6.2 shall be used solely for the purpose of allowing a Regulatory Authority to access the clinical data and other information contained in the Design Dossier, Cordis PMA, or other regulatory body registration or licensing submission and/or related documentation for the purposes of regulatory clearance or approval of the Licensed Products.

Related to Design Dossier

  • Design-build team means an entity that consists of:

  • Design-Builder means the Person/Firm(s)/Joint Venture selected pursuant to the RFP that enters into the Contract with the Department to design and construct the Project.

  • Design-Build Firm means a partnership, corporation or other legal entity that:

  • Design Documents means, collectively and as applicable, the Conceptual Design Documents, Schematic Design Documents, the Design Development Documents and the Construction Documents prepared by the Trade Contractor.

  • Design flow means the average annual flow or average daily flow specified in an approved facilities plan or approved plans and specifications, the flow specified in a WPDES permit, or the flow required to meet performance standards.