How to Get CE Certification
With our expert consultants, QCS can help you to successfully achieve CE Certification and the regulatory compliance required to bring your products to market within the European Union (EU).
We can assist in various ways from the launching of a new product to major changes to existing products, QCS can provide cost-effective expertise throughout the regulatory approval process.
Obtaining CE Certification of your medical device in the EU requires:
- Preparation of a CE Marketing Technical File or a Design Dossier (for a Class III device) that includes data demonstrating compliance with the MDD, IVDD or AIMD.
- Obtain your CE Marking certification from a Notified Body or self- certify your compliance with the MDD (Class I non-sterile, non- measuring devices).
Completion of these requirements allows you to claim CE Marking certification for your device and with QCS we can assist you to attain this in a shorter time scale using our experts.
