What cybersecurity evidence should a medical device premarket submission contain?

1 company with a published answer

  1. Pure Global

    “The evidence should be scaled to the device's cybersecurity risk and submission type. Depending on applicability, it can include security risk-management documentation, threat modeling, architecture views, security requirements and traceability, cybersecurity testing, unresolved anomaly assessment, an SBOM, labeling, and plans for vulnerability monitoring, coordinated disclosure, updates, and patches.”

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Data formats and record details
Surface ID
urn:readyscan:corpus:buyer-question:pure-global-q136308885-answer-137d5c667ca0bd43463f
Material fingerprint
fnv1a64:5a1b1daa7fac67b1
Membership fingerprint
fnv1a64:8a1849c73c1d3cab
Published
2026-10-28
Modified
2026-10-28
ready-scan-subjects/Q136308885
revision Q136308885:content:3e9a0682a149553c

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