Clinical Investigations and Clinical Monitoring
Clinical investigations are carried out for medical devices with and without CE marking. According to ISO 14155, each systematic evaluation or study performed on human beings to assess the safety and/or capability of a medical device is defined as clinical investigation.
In each study, the test person's safety always has top priority. Therefore, a clinical monitor is used to verify this circumstance as well as data validity. The target parameters and the pertaining number of test persons of a clinical investigation may vary significantly and must be developed individually for each project.
Bring us in at an early planning stage and we will ensure that your study follows a sustainable design and produces valid data. Our engineers are experienced and familiarize quickly with your test product so that we are able to run the required tests for the study design promptly. During the study we are available as a competent partner for your test body and provide regular updates about the study so that you may fully concentrate on your core competences.
Our services in detail
T: +49 621 123469-19
"Our strength? We cannot hold our tongues. If you bring us in during the planning phase of your study, we draw your attention to all relevant aspects in good time. We are your partner for discussion and contact for your test bodies."