MDS2 (Medical Device)
Audit Logging Integrity and Cybersecurity Risk - MDS2

MDS2 (Medical Device) Audit-Logging-AUDT-Integrity-IGAU-Cybersecurity-Risk-CYBR-Monitoring: MDS2 Audit Controls + AUDT + Integrity + IGAU + Cybersecurity Risk + CYBR + Continuous Monitoring

Disclose and operate audit logging + integrity assurance + cybersecurity risk management features per MDS2 AUDT + IGAU + CYBR sections. Audit Controls (AUDT) including audit event coverage (logon + logoff + access + privileged operations + configuration changes + security tool events) + log retention duration + log integrity protection + SIEM integration + syslog/CEF/IPFIX export. Integrity and Authenticity Assurance (IGAU) including digital signature verification + secure boot + signed firmware updates + tamper detection + chain of custody + integrity monitoring. Cybersecurity Risk Management Practices (CYBR) including manufacturer cybersecurity risk management process + Secure Development Lifecycle (SDLC) attestation + threat modelling + penetration testing + vulnerability management + coordinated disclosure programme + ISO/IEC 27001 + ISO/IEC 27034 alignment + IEC 62443 alignment + NIST CSF / NIST 800-53 / NIST 800-30 alignment + Software Bill of Materials (SBOM) disclosure (added 2022 update aligned with FDA Section 524B + NTIA SBOM minimum elements + CISA SBOM guidance). Continuous monitoring evidence + intrusion detection capability.

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