Turn local security scans into FDA-submission-focused evidence.
SCS helps Medtech regulatory and software teams produce FDA-submission-focused SAST and SBOM reports from local or CI scans, without sending source code outside their environment.
Security evidence built from the workflow teams already use.
Built for medtech and regulated software teams that need practical developer feedback and credible evidence for medical device submissions and design records.
Scan code and SBOMs where they live
Run the Docker-based scanner locally or in CI, upload structured scan output, and keep code-egress controls practical.
Prioritize SAST findings with AI-assisted triage
Flag likely false positives, explain confirmed issues, and give developers remediation guidance they can act on.
Review SBOM readiness against FDA guidance
Upload, review, validate, annotate, and export SBOMs with readiness workflows mapped to FDA guidance.
Produce FDA-submission-focused reports
Generate SAST and SBOM PDF evidence packages with summaries, scan history, findings, readiness, and submission evidence context.
From scanner output to submission-focused evidence.
SCS turns raw scanner output, SBOM files, and CI/CD signals into structured outcomes your team can review, gate, and export for submission work.
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Step 1
Run scanner
Use the SCS CLI in a local workspace or pipeline to collect SAST and SBOM data.
SAST + SBOM data -
Step 2
Upload results
Attach project, branch, commit, token, and scan configuration context.
Scan context -
Step 3
Review evidence
Triage findings, inspect SBOM readiness, and capture FDA guidance review decisions.
Review decisions -
Step 4
Export reports
Produce SAST and SBOM evidence packages for FDA submissions and internal design records.
Evidence packages