Audit‑Ready Post‑Market Surveillance
Erythos monitors new clinical evidence, extracts traceable claims, flags safety/performance deltas, and produces auditor‑defensible outputs — without spreadsheet chaos.
Built for Regulatory Affairs, Clinical Affairs & Quality teams managing EU MDR / IVDR compliance
EU MDR Made Monitoring Continuous — Your Workflow Stayed Manual
MDR Articles 83‑86 and MDCG 2022‑21 require ongoing vigilance. Excel won't cut it.
The Compliance Gap
- 📋PubMed alerts dumped into Excel — no traceability
- ⚠️Safety signals buried in 100‑page papers
- 📝Manual CER/PSUR updates every 2–5 years
- ❓No clear audit trail linking evidence → claims → actions
With Erythos
- Claim‑aware delta monitoring flags what actually matters
- Every claim linked to source → paragraph → resolution
- Living PMS that feeds directly into CER/PSUR sections
- Auditor‑defensible exports with full provenance
How It Works
Ingest Evidence Sources
Connect PubMed, Embase, or upload PDFs. Erythos extracts structured claims automatically.
Define Your Claims
Enter the claims from your IFU, CER, or Technical File. Erythos monitors evidence against each claim.
Monitor + Resolve
Deltas surface automatically. Resolve with rationale, then export auditor‑ready PMS reports.
Pricing
Priced per device family. Start with a pilot, scale as your portfolio grows.
Pilot
Prove the workflow on a single product line.
- Full Claim Ledger
- Delta monitoring
- PMS export
- Email support
Team
For growing regulatory teams.
- Everything in Pilot
- Multi‑user collaboration
- CER/PSUR templates
- Priority support
Scale
Enterprise deployment + integrations.
- QMS / eQMS integration
- SSO & audit logs
- Dedicated CSM
- SLA guarantee