Need a clinical trial for a medical device in Europe? Could your technology lead to an innovative medical application? CERES can help you to access the European market! A clinical trial is conducted to determine the safety and performance of
Do you need a clinical evaluation to achieve CE approval, or to determine the safety and performance of your medical device? The clinical evaluation is a document that evaluates whether your device is at least as safe and effective as
Does your device already has CE approval and do you need a Post-Market Study? Goals of Post-Market studies are market surveillance by means of Post-Market Clinical Follow-up (PMCF) studies market release and introduction of your new device or technology exploration
We think in Medical Devices. We support you in the creation of a clinical-regulatory strategy, process optimization and product development. For ■ business development ■ optimization of your product portfolio or ■ implementation of the MDR. We provide competent answers
Adverse events and incidents. As a medical device manufacturer and distributor, you know that medical devices must meet the requirements both in routine use as well as during a clinical trials. In Europe, this is currently done in accordance with
In our moderated workshops, we address your company-specific requirements. We pick up your current situation and lead you to a needs-based formulation of your goals. This common goal formulation depends on your question as well as on the workshop participants,
Clinical & Regulatory Strategy
For business development, optimization of the product portfolio, or implementation of MDR requirements ...