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.
Study management

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

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Clinical Evaluation

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

life cycle

Post-Market Studies

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

Hands

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 provide competent answers

MDR, PMCF, ISO 14155, Monitoring

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

Workshop

Workshops

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 ...

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