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Qserve Group Qserve Consultancy Training Regulatory Affairs Technical file

Course code RA3


Technical File


Course description:

This course is intended to provide a basic overview of making a technical file for conformity assessment for medical devices.

  • Preparation and submission of CE Technical file(s) and CE Design dossier(s)
  • Advice on and evaluation of the Risk Management system
  • Advice on and review of the Essential Requirement(s)
  • Labeling and language compliance
  • Declaration of Conformity
  • Expert reports and other technical documentation
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