Clinical Studies

Today, it’s your turn!

The goal of clinical studies is always to demonstrate or confirm the safety and performance of your product through your own clinical data. The requirement for clinical studies can apply to your medical device both before the declaration of conformity and after it has been placed on the market. This is not only the case for high-risk products and innovative products without a comparable alternative but can also apply to established products. Depending on the development stage of your medical device and the objectives of the study, different articles of the MDR apply, and you must consider various regulatory requirements, for example, in the preparation of the study.

We make it easier for you to decide which type of clinical study is suitable in your case. Read more about the different types of studies in our “Expert Knowledge” section.

From planning to the final report and publication

For many years, we have been supporting medical device manufacturers at both national and international levels in the planning and conduct of clinical studies. We keep regulatory requirements in mind and guide you safely, quickly, and reliably through the various phases of the study: from formulating objectives to preparing the final report and publication. We are also happy to take on individual tasks for you, according to your needs. In doing so, we help you avoid errors in planning, execution, and data interpretation. With our interdisciplinary team of experts for clinical studies, we walk this path together with you.

Our range of services covers the essential aspects of a clinical study:

Would you like to get to know us? – Get in touch with the experienced novineon experts today to lead your study to success efficiently and pragmatically!