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.
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
- Liaise with and act as your primary contact with the competent authorities and notified bodies during both the pre- and post market phases
- Ensure post market obligations are met
- Act as your main contact in case of vigilance issues
- Act as your main contact in case of batch recalls
Why QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS​
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.
