novineon - turning hurdles into milestones!

For more than two decades, novineon CRO has been a leading service provider supporting manufacturers of medical devices and in vitro diagnostics on their path to market success. In our work, we combine profound regulatory knowledge with scientific precision – exactly what manufacturers need to meet the complex requirements of the medical technology industry.

We understand the challenges in developing and assessing conformity of medical devices and beyond. From defining the intended purpose to creating clinical evaluations and conducting clinical studies, we offer tailored solutions for your specific device.

For manufacturers with international ambitions, we efficiently support the approval process in the USA, Canada, and other markets in South America and Asia. By intelligently linking European and international approval strategies, we optimize your resources and significantly accelerate market access.

We also offer comprehensive support for manufacturers of in vitro diagnostics with the special regulatory requirements of the IVDR.

Your medical device deserves experts who speak your language. Together, we transform regulatory hurdles into milestones on your path to success.