CERES helps medical device manufacturers to gain access to the European market. As a full-service contract research organization, we are specialized in clinical trials and clinical evaluations for medical devices. Together we develop the right clinical and regulatory strategy for you. We can do your entire study, or provide you with exactly the help you need to succeed.
Clinical Trial

Clinical Trial

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

Clinical Evaluation

Clinical Evaluation

Need a literature-based clinical evaluation to achieve CE approval, or to determine the safety and effectiveness of your medical device? A literature-based clinical evaluation is a document that evaluates whether your new device is at least as safe and effective

Post-Market Studies

Post-Market Studies

Your device already has CE approval and you need a Post-Market Study? Goals of Post-Market studies are market surveillance by Post-Market Clinical Follow-up (PMCF) studies market release and introduction of your new device or technology explore or improve device acceptance

Consulting

Consulting

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 support questions about

Vigilance

Vigilance

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

Workshops

Workshops

In our moderated workshops, we address your company-specific requirements. We pick up your current situation and lead you to a needs-oriented 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 ...

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