Your Professional CRO-Team for Medical Devices
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.
We are with you every step!
As a Contract Research Organization (CRO) for medical devices, we are experienced in delivering customized solutions for your Clinical Product Lifecycle strategy: studies for the initial conformity assessment as well as PMCF studies. Post-Market Clinical Follow-up (PMCF) is an essential part of market surveillance and required by (EU) 2017/745. We offer digital solutions (e-PMCF) for the generation of PMCF data, a special service for the professional, continuous evaluation of clinical data.
From Start-up to global Player
Our offer is aimed at established medical device manufacturers and ambitious start-ups that want to enter this market. For all of these, the introduction of MDR (Medical Device Regulation, EU Regulation 2017/745) and EU Regulation 2017/746 on IVDR brings high demands on the development and marketing of medical devices and in vitro diagnostic medical devices.
Services
we provide
Clinical Investigations
Need a clinical study for a medical device? Could your technology lead to an innovative medical application?
Medical/Regulatory Writing
CERES has extensive medical device experiences within Regulatory, Quality and Clinical Affairs. Devices from class III to I, or implants and active implants are subject of our Medical Writing services.
Post-Market Clinical Follow-up
Does your device already have CE approval and do you need a Post-Market Clinical Follow-up measure?
Consulting
We continuously support you in the developement of a clinical-regulatory strategy, and the optimization of your processes and product Pipeline.
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.