Clinius Ltd Information

Clinical device trial and QARA specialist Clinius helps manufacturers build clinical trials that meet MDR requirements and support the marketing of medical devices. Clinical device trials – reliably and with practical experience We conduct MDR‑compliant clinical device trials in accordance with ISO 14155 and the Declaration of Helsinki. Our in‑house study team ensures high‑quality data collection, smooth patient workflow, and controlled study progression from start to finish. Our key services: – Clinical Trials – Clinical Evaluation Plan (CEP) – Clinical Evaluation Report (CER) – AI‑assisted literature reviews – Technical documentation (MDR) – QMS (ISO 13485) – CEP–CER–trial alignment – Training