14. helmikuuta 2024

Clinical device trials in accordance with the requirements of the MDR

Clinius is a pioneer of clinical device trials in Finland. We have more than 15 years of experience in both clinical trials and cooperation with healthcare organizations. We carry out the planning, preparation and implementation of the trial taking into account the requirements of both the MDR and the ISO 14155 clinical research standard.

As a partner, Clinius offers a wide-ranging vision for device trials, long-term experience in the practical implementation of trials, and an experienced multi-professional team for all stages of the trial. To ensure the best outcome, it is important to be on the move in a research project on time.

We can comprehensively help in the planning of trial needs and the trial itself, in the selection of researchers and trial locations, implementation and reporting. We also offer biostatistics services for the project.

We carry out clinical device tests either on a turnkey basis or by producing needed parts and tasks. We also help in evaluating the necessary studies and planning the road map. Our services also include clinical evaluations (CER), clinical evaluation plans (CEP) and PMCF. Contact us today!