Too many great products fail to reach consumers because of poor marketing. Even worse, what happens if a great product gets recalled because it was unable to meet industry regulations?
Don’t let either of these happen to you.
If you’re ready to put your product on the market, it’s essential it meets all regulatory requirements. To sell legally, all medical devices sold in Europe must bear the CE mark. We can help you on the way.
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