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Medical Device Cybersecurity Auditor | exact.works

RepositoriesMedical Device Cybersecurity Auditor

exact.works / Medical Device Cybersecurity Auditor

FDA premarket cybersecurity requirements assessment for medical devices with SBOM analysis.

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Completion Criteria

FDA cybersecurity guidance compliance assessed

SBOM analyzed for known vulnerabilities

Threat model documentation reviewed

Use Cases

Premarket submission preparation

510(k) cybersecurity documentation

Post-market cybersecurity assessment

Not Suitable For

Device software development (assessment only)
Penetration testing of devices

Activity

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FDA premarket cybersecurity requirements assessment for medical devices with SBOM analysis.

FDA medical device cybersecurity SBOM threat modeling 510(k)premarket

TypeScript

Healthcare / Life Sciences

Discrete, Continuous

Contributors

1 contributor

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Trust Signals

SAISA-compiled

Independent review

Hash chain verified