Reguverse AssistantAI-Powered Medical Device Regulatory Platform

From clinical evaluation to post-market surveillance -- an all-in-one AI compliance documentation solution

EU MDR Clinical Evaluation

Complete clinical evaluation in 10 steps with automated CEP, CER, and DCR document generation

AI-powered analysis of device applicability against EU MDR Annex I requirements

Structured hazard identification and control measures with automated risk matrix generation

Full PMS/PMCF coverage including PMS Plan, PMCF Plan, CE Update, PMCF Report, and PSUR

Generate registration materials following eRPS chapter structure for imported and domestic devices

Device classification, equivalent device research, translation, EUDAMED UDI bulk upload