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We have the expertise to set up and manage clinical trials designed to demonstrate clinical safety and performance of a medical device for CE Marking
Medical devices can only be introduced in the EU market after having been approved and deemed suitable, safe and effective.
Medical devices in the EU must be CE-certified. A CE mark will be attached to the medical device provided that the necessary essential requirements have been fulfilled and after having conducted the compliance assessment procedure. In the EU “notified bodies” are responsible for assessing compliance of medical devices with the relevant directives.
We have the expertise to set up and manage clinical trials designed to demonstrate the clinical safety and performance of a medical device for CE Marking.
Services for Medical Device Clinical Trials:
Clinical Trial Design and Start-UpProject ManagementClinical MonitoringData Management and EDCStatisticsData StandardizationMedical and Scientific Writing