Pioneer in clinical device trials

We provide MDR‑required clinical device trials, Clinical Evaluation Plans (CEP), and Clinical Evaluation Reports (CER). We conduct studies in accordance with ISO 14155 and the Declaration of Helsinki – with know-how that is based on hospital collaboration that began in the late 1980s to develop the functionality and usability of the devices.

Design, execution, and documentation according to MDR

Clinius conducts clinical device trials for manufacturers who need documented clinical evidence to demonstrate product performance, support market access, or conduct post‑market follow‑up.

The service includes:

·  Study design
   – Appropriate scope, correct endpoints
   – Study protocol preparation and documentation

·  Study execution
   – Regulatory approvals
   – Recruitment and data collection with our in‑house study team
   – Site coordination and collaboration

·  Data collection, analysis & quality assurance
   – Electronic data capture (EDC)
   – Statistical analyses, biostatistics
   – Monitoring

·  Reporting
   – Study report integrated into the clinical evaluation process