Clinical evidence reviews for CER, PMCF and PMS require teams to screen literature, extract clinical performance and safety evidence, and maintain traceability across evolving post-market data. Biolevate helps MedTech teams scale evidence review while preserving source-linked rationale and expert review.
Faster CER evidence reviews
Accelerate CER, PMCF and PMS evidence reviews by automating literature retrieval, screening, structured extraction and source-linked synthesis.
Broader clinical evidence coverage
Scale review across more articles, equivalent devices, clinical investigations, PMS inputs and safety sources with consistent extraction logic.
Traceable CER rationale
Keep clinical performance, safety and benefit-risk conclusions linked to source passages, extracted fields and reviewer decisions.
How it works
1
Retrieve and structure evidence — collect literature, clinical investigation data, PMS/PMCF inputs, equivalent-device evidence and safety sources into a governed corpus.
2
Define screening and extraction logic — set inclusion criteria, device scope, endpoints, populations, comparator logic and CER/PMCF fields.
3
Extract clinical and safety evidence — structure performance, safety, equivalence, limitations and post-market findings into reviewable tables.
4
Generate CER-ready synthesis — produce evidence tables, summaries and source-linked rationale for expert validation and documentation updates.
MDR/IVDR-ready traceability: every extracted claim, endpoint, safety finding and equivalence rationale is linked to source evidence and a run record.
Reusable clinical evidence base: structured CER, PMCF and PMS evidence becomes a living asset for updates, notified-body questions and roadmap planning.