1 Medical Device Regulatory Compliance Consultants - Technical File

 
 
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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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