MedTech teams must translate intended purpose, clinical claims and market strategy into CER, PMCF and PMS evidence needs. Biolevate maps existing evidence to claims and requirements, identifies gaps and supports roadmap prioritization.
Faster CER/PMCF gap mapping
Turn intended purpose, clinical claims, market expectations and existing evidence into a structured CER/PMCF claim-to-evidence matrix faster.
Late evidence gaps identified earlier
Surface missing, weak or misaligned evidence with a gap heatmap across clinical claims, endpoints, populations, equivalence, PMS and PMCF needs.
Evidence roadmap by claim
Prioritize next evidence-generation actions — PMCF studies, PMS analyses, literature reviews, CER updates or risk-file updates — with source-linked rationale.
How it works
1
Ingest clinical strategy and claims — structure intended purpose, clinical claims, device scope, market objectives and existing evidence packs.
2
Benchmark expectations — capture MDR/IVDR, PMCF, PMS, clinical evaluation and market-specific evidence needs.
3
Build the evidence matrix — map claims, endpoints, populations and device evidence to source documents, confidence levels and gaps.
4
Generate the roadmap — prioritize PMCF, PMS, literature review, CER update and risk-file actions with traceable rationale.
CER/PMCF claim-to-evidence matrix: map each clinical claim to available evidence, source documents, market expectations and confidence level.
Gap heatmap + roadmap: translate weak or missing evidence into prioritized actions by intended purpose, endpoint, device family, market and lifecycle objective.