Meet the requirements of the European CE marking process
Contact with authorities & notified bodies during the whole marketing process
Test your product before entering the market
Get your technical documentation right
Make sure your dossier contains all essential requirements
Classify your devices correctly
Align artwork and labels with your technical file
Keep abreast of changes in regulations and standards
An appropriate system of vigilance and Post Market Surveillance (PMS)
Formulate procedures to assure control of production and processes
Review your information