Working with Blue Goat
What full-service FDA premarket cybersecurity includes
Every deliverable in the full-service FDA premarket cybersecurity package, grouped the way the FDA reviews them.
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Six deliverable groups
- Risk management
- Risk management report, threat model, cybersecurity risk assessment, unresolved anomalies, and measures and metrics.
- Software and components
- SBOM, component support status, and end-of-support plan.
- Requirements and architecture
- Security requirements, security architecture views, and interoperability risk assessment.
- Testing
- Static analysis (SAST), pen test plan and cases, and penetration test report.
- Labeling
- Cybersecurity labeling, MDS2, and interoperability labeling.
- Management plan
- Cybersecurity management plan.
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