Clinius is a Finnish pioneer in clinical device trials, experience starting from late 80's with hospital co-operation to develop the functionality and usability of the medical devices. We continue to carry out all device studies with this knowledge base. We offer comprehensive clinical evaluation, clinical trial and testing services either comprehensively on a turnkey basis or by offering individual services for the customer's project. Device studies are also easier to manage and monitor using the study management software (EDC / eCRF), which we offer as a service.
In clinical device trials, we follow the Helsinki Declaration of the World Medical Association and the research-related standard ISO 14155. The results can be used either as such or in applicable parts for demonstrating compliance (CE marking), in further product development and marketing.
Our services include
• Clinical evaluation (CER)
• Clinical device trial
• Performance evaluation (IVD)
• Trial management sw (EDC / eCRF) as a service
• Usability testing
• Post-market surveillance