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CATÉGORIE: QUALITY SYSTEMS

Gestion des risques

L'application systématique de politiques de gestion pour analyser, évaluer, contrôler et surveiller les risques tout au long du cycle de vie du dispositif.

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

  1. Establish risk management plan and team.
  2. Analyze hazards; estimate/evaluate risks.
  3. Implement and verify risk controls.
  4. Review residual risk and production/PMS feedback.

EXAMPLES

  • A software update that changes clinical decision logic requires risk file revision.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

ISO 14971 (Gestion des risques)Actions correctives et préventives (CAPA)