If you’re ready to put your product on the market, it’s important that it meets all regulatory requirements.
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.
Why not put the whole process into Aurena’s hands?
Make sure your products are fulfilling all legal requirements can be a frustrating and slow process. All medical devices sold in Europe must bear the CE mark to be legally sold.
Our process is done efficiently and effectively. It includes:
- Device classification
- Evaluation and substantiation of product claims
- Preparation of the technical documentation and file
- Audit and notification process
