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