Confidence in your product's compliance
Clinius provides trial‑driven support for MDR and IVDR compliance as well as development of technical documentation and quality management systems. Our services are based on over 15 years of experience in medical device trials, documentation, and ISO 13485 systems.
Our services include
·
MDR/IVDR & technical documentation
– Product classification, regulatory strategy
– Technical documentation and compliance
· Quality management system (ISO 13485)
– QMS design and implementation
– Risk management according to ISO 14971
– Pre‑audits and quality manager service
· Clinical evidence support
– CEP & CER as part of a trial‑driven evidence model
– Post‑market surveillance (PMS) & PMCF studies
