Bußgelder wegen fehlender Kalibrierungs- und Wartungsdokumentation (MPBetreibV)
Definition
Operators of medical devices face mandatory documentation of calibration and maintenance per MPBetreibV, with failures risking fines during Betriebsprüfungen or regulatory inspections.
Key Findings
- Financial Impact: €5,000-50,000 per violation (typical Betriebsprüfung fines); 20-40 hours/month manual logging per lab
- Frequency: Annual inspections required; audits every 3-5 years
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Medical and Diagnostic Laboratories.
Affected Stakeholders
Lab managers, Technicians, Compliance officers
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
Kosten durch Nacharbeiten und Haftung bei Kalibrierungsfehlern
Ausfallzeiten durch unzureichende Wartungsprotokollierung
Verpasste Erstattungen bei Eligibility-Fehlern
IVDR-Verstöße in Diagnostiklabors
Verzögerte Abrechnung durch ePA-Integration
Kapazitätsverlust durch manuelle Prüfungen
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