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KATEGORIE: QUALITY SYSTEMS
Risikomanagement
Die systematische Anwendung von Managementrichtlinien zur Analyse, Bewertung, Kontrolle und Überwachung von Risiken im gesamten Produktlebenszyklus.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Risk management systematically identifies, evaluates, controls, and monitors hazards throughout the device lifecycle—typically per ISO 14971 integrated with QMS and clinical evaluation.
PROCESS / STEPS
- Establish risk management plan and team.
- Analyze hazards; estimate/evaluate risks.
- Implement and verify risk controls.
- Review residual risk and production/PMS feedback.
EXAMPLES
- A software update that changes clinical decision logic requires risk file revision.
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SOURCES
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