DocuGenius accelerates Clinical Evaluation Reports for MDR and Performance Evaluation Reports for IVDR. Cut literature-review time in half without losing the audit trail.
The clinical evaluation report bottleneck is the systematic literature review: screening, appraising, and traceably documenting hundreds of records. DocuGenius runs a PRISMA-aligned review and keeps the audit trail, so the CER is defensible and the cycle drops from weeks to days.
Three steps: harvest, screen, write. Every screening decision logged for the appendix.
Multi-source ingestion (PubMed, Embase, internal evidence). Automated deduplication and PRISMA flow generation.
Agentic screening against your inclusion criteria. Every accept/reject is justified and reviewer-overridable.
Pre-validated state-of-the-art, benefit-risk, and clinical-data sections - drafted for medical-writer review, not auto-published.
50%
Lit-review time cut on first pilot vs. manual screening.
100%
Of screening decisions logged with rule trace.
MDR + IVDR
Same engine handles CER and PER without re-implementation.
A 15-minute walkthrough on a real document — yours or ours. Pilot environment live in under a day.
Each incumbent owns a slice. DocuGenius handles screening AND drafting AND on-prem.
DocuGenius
Harvest, screen, and draft sections in one platform.
Single-purpose CER tools
DistillerSR screens. CiteMed harvests. CAPTIS drafts. You stitch.
DocuGenius
Every decision versioned, with rule, model, and prompt logged.
Single-purpose CER tools
Spreadsheet exports - not designed for an MDR audit timeline.
DocuGenius
EU on-premise available from day one.
Single-purpose CER tools
Mostly SaaS-only. EU on-prem rarely offered.
Share your use case, we'll come prepared
What you'll get
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