CE-marking and Regulatory Support

Let’s get your product on the market.

If you’re ready to put your product on the market, it’s important that it meets all regulatory requirements. All medical devices sold in Europe must bear the CE mark to be legally sold.

Put this process into Aurena’s hands

We work with our clients to assemble the technical documentation and prepare the audit and notification process that will help you get your product on the market – efficiently and effectively, including:

  • Device classification
  • Evaluation and substantiation of product claims
  • Preparation of the technical documentation and file
  • Audit and notification process
Contact Us

Partner with Aurena to get your product compliant and in market sooner.