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.
Let’s get your product on the market.
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