Course code RA2

Course " Medical Device Directive Compliance" with exam (2 days)

Course description:

This two-day comprehensive course provides participants with an in-depth understanding of the requirements of the EU Medical Device Directives and the CE Marking approach and focuses on the Medical Devices Directive (MDD) including active and non-active medical devices. It gives participants the latest information regarding the interpretation and enforcement of these Directives. Most importantly, it facilitates your company to put medical devices on the EU market (25 countries and still expanding) more quickly!

• Device classification
• CE Marking of medical devices conform the European Medical Device Directive(s)
• Choice of your Notified Body
• Conformity route assessment
• Representing your company to national and international regulatory authorities
• Pre-clinical testing
• labeling
• packaging
• Design and risk analyses
• Advice on the implementation of a Complaint, Recall, and Vigilance system
• Post Market Surveillance (PMS) system

• 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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