KATEGORIE: STANDARDS

Cybersicherheit von Medizinprodukten

Der Schutz vernetzter Medizinprodukte vor unbefugtem Zugriff und Cyberangriffen.

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

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

EXAMPLES

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

RELATED GUIDES & TOOLS

SOURCES

FDA Cybersecurity ↗

Track regulatory signals related to Cybersicherheit von Medizinprodukten across 27 authorities in real time.

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