CERES in co-operation with leading medical device manufacturers
Our customers are medical devices manufactures from Class III to Class I devices according to MDD, as well as active implantable medical devices (AIMD).
Most of our customers are mid-sized companies, with 20-200 employees. We also have experience with several global companies with over 40.000 employees, as well as with some small companies, and start-ups with less than 10 employees.
Our worldwide customers are e.g. engaged in medical fields, such as:
- invasive cardiology
- vascular and general surgery
- neurology and neurosurgery
They all strive to interact with the European medical device market. They wish to explore device feasibility, conduct a first-in-human study, achieve CE approval with a literature-based clinical evaluation or a clinical trial, or to gain assistance with Post-Market Clinical Follow-up.
Whatever goal you have, CERES helps you access and maintain the European market, and to use your experiences for future innovations!
If you aim to achieve FDA approval in the USA, you may wish to seek CE approval in Europe first, since the timeline to obtain a CE Mark is typically more efficient than the timeline to gain FDA approval. Moreover, clinical data obtained from investigations prior to CE approval in Europe can support your application for FDA approval.