From CE marking to PMCF, data that safeguards.
SMEs, mid-size companies and medical device manufacturers: we support your MDR clinical investigations, performance studies and post-market surveillance. Exagis CDMS platform adapted for medical devices, biostatistics and data management under one roof.
From protocol design to database lock
We cover the entire lifecycle of an MDR clinical investigation — interventional or observational, CE marking or post-market surveillance.
MDR clinical investigations
Interventional studies for CE marking: protocol design per ISO 14155, CPP/ANSM submission, centralised monitoring, clinical investigation report.
Post-market clinical follow-up (PMCF)
Post-marking observational studies required by the MDR. Long-term registries, tolerance follow-up, real-world performance. Format adapted to the required evaluation frequency.
Exagis CDMS adapted for MD
Our proprietary platform configured for medical device specificities: implant/series data capture, operative photos, technical measurements, patient ePRO for home follow-up.
Biostatistics & data management
Statistical analysis plan, sample size calculation, centralised randomisation, MedDRA coding, CDISC SDTM database lock. Full biostatistics service under one roof.
Pathologies & technologies we support
Preparing a medical device clinical investigation?
CE marking, PMCF or performance study — describe your project and we will respond with a methodological and budgetary framework within 24 business hours.
Book a meeting