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CE Marking

CE marking signifies that products sold in the EEA (European Economic Area) have been assessed to meet high safety, health, and environmental protection requirements.

QbD supports companies in all matters of vigilance, in order to be fully compliant.

CE Marking

Important steps to obtaining a CE mark:

  • Verify the essential requirements
  • Classify the product
  • Choose a conformity assessment route
  • Test the device for safety and effectiveness by carrying out appropriate pre-clinical and clinical tests or literature reviews
  • Compile a technical file outlining the pre-clinical, clinical and manufacturing steps related to the device
  • Implementation and maintenance of ISO 13485 quality systems
  • Perform risk assessment and management -ISO 14971
  • Implement a vigilance and Post Market Surveillance (PMS) system
  • Make sure to have a European Authorised Representative

How we support you

Why opt for the QbD Group?


10+ years of experience

Benefit from our team of highly qualified consultants.

Full life cycle support

Full support from pre- to the post-marketing phase.

Global presence

QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.

Customer satisfaction

Constant evaluation, transparency and clear objectives.

Contact us

Talk to an expert

Contact us for more information or to request a free, no-obligation proposal.