Reklamationskosten durch unkalibrierte Messgeräte
Definition
Ophthalmic diagnostic instruments (Class IIa/IIb) require ongoing calibration under ISO 13485 QMS. Poor manual logging results in patient complaints, refunds, and BfArM vigilance reports.
Key Findings
- Financial Impact: €2,000-10,000 per warranty batch; 2-5% revenue from refunds
- Frequency: Per uncalibrated device use (monthly for high-volume practices)
- Root Cause: Idle/uncalibrated equipment due to lost manual logs; no PRRC oversight
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Optometrists.
Affected Stakeholders
Optometristen, Qualitätsmanager, Patientenservice
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
BfArM-Nachweispflichten bei Kalibrierungsfehlern
Ausfallzeiten durch fehlende Wartungsnachweise
Manuelle Nachbestellzeiten
Kapazitätsverlust durch manuelles Inventarmanagement
Umsatzverlust durch Inventarfehler bei Contact Linsen
Inventar-Diebstahl und -Schwund bei Brillen und Linsen
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