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CATÉGORIE: STANDARDS

Cybersécurité des dispositifs médicaux

La protection des dispositifs médicaux connectés contre les accès non autorisés et les cyberattaques.

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

Medical device cybersecurity covers design, labeling, and postmarket management of threats to device safety/effectiveness—especially for connected and software devices.

PROCESS / STEPS

  1. Threat model during design; apply secure development practices.
  2. Document SBOM and updateability where expected.
  3. Plan coordinated vulnerability disclosure and patches as FSCA when needed.
  4. Monitor field signals for exploit patterns.

EXAMPLES

  • Connected infusion pumps and imaging systems are frequent cybersecurity focus areas.

RELATED GUIDES & TOOLS

SOURCES

Track regulatory signals related to Cybersécurité des dispositifs médicaux across 27 authorities in real time.

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