medsbom 0.1.0

Open-source FDA/IEC-62304 compliance layer for medical device SBOMs

🏥 MedSBOM

Open-source FDA/IEC-62304 compliance layer for medical device SBOMs

Turn raw SBOM scans into FDA-submission-ready documentation in seconds, not weeks.

Quick Start • Examples • API Docs • Contributing • Sponsor

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The Problem

Medical device manufacturers must (FDA 2023 guidance, PATCH Act, 2026 QMSR):

• Maintain Software Bills of Materials for every device
• Continuously monitor SOUP components for vulnerabilities
• Document a Secure Product Development Framework
• Produce audit-ready evidence of regular vulnerability review (IEC 62304 §7.1.3)

Today: Teams spend 40–80 hours per device manually translating Syft/Grype/Trivy output into regulatory documents. Paid platforms charge $50K–$200K/year.

With MedSBOM: One command. Audit-ready docs in seconds. Free forever.

What MedSBOM Does

┌─────────────┐     ┌──────────────┐     ┌───────────────────────────┐
│  SBOM Input │ ──▶ │  MedSBOM     │ ──▶ │  FDA Premarket Summary    │
│ (SPDX/CDX)  │     │  Engine      │     │  SOUP Risk Assessment     │
└─────────────┘     │              │     │  Vulnerability Review Log │
                    │  • CVE match │     │  Audit Trail              │
┌─────────────┐     │  • KEV check │     └───────────────────────────┘
│ NVD + KEV   │ ──▶ │  • EOL check │
│ feeds       │     │  • Risk score│
└─────────────┘     └──────────────┘

Quick Start

Install

pip install medsbom

Generate your SBOM (if you don't have one)

# Using Syft
syft dir:./my-firmware -o cyclonedx-json > my-device.sbom.json

# Using Trivy
trivy fs --format cyclonedx --output my-device.sbom.json ./my-project/

Run MedSBOM

# Check for vulnerabilities and EOL status
medsbom check my-device.sbom.json --device "Insulin Pump" --device-version "2.3.1"

# Generate FDA compliance documents
medsbom report my-device.sbom.json --format all --output ./compliance-docs/

That's it. You now have:

• fda_premarket_summary.md — Maps to FDA 2023 Cybersecurity Guidance structure
• soup_risk_assessment.md — IEC 62304 §7.1.3 SOUP register with risk levels
• vulnerability_review_log.md — Timestamped audit evidence

Features

Feature	Description
SBOM Ingestion	CycloneDX and SPDX JSON (from Syft, Trivy, or any scanner)
CVE Matching	Cross-reference against NVD with local caching
CISA KEV	Flag actively exploited vulnerabilities
EOL Detection	Check end-of-life status via endoflife.date
Risk Scoring	Composite score: CVSS + KEV + EOL proximity
FDA Docs	Premarket Cybersecurity Summary template
IEC 62304	SOUP Risk Assessment table
Audit Trail	Immutable, append-only log for regulatory evidence
REST API	FastAPI server for integration and dashboards
Docker	Single container, no external dependencies

CLI Commands

medsbom ingest <sbom-file>          # Parse and validate an SBOM
medsbom check <sbom-file>           # Vulnerability + EOL check
medsbom report <sbom-file>          # Generate compliance documents
medsbom audit                       # View audit trail
medsbom version                     # Show version

API

Start the API server:

uvicorn medsbom.api.main:app --host 0.0.0.0 --port 8000

Endpoints:

• GET /health — Health check
• POST /api/v1/scans — Upload SBOM and run analysis
• GET /api/v1/scans/{id} — Get scan results
• GET /api/v1/scans/{id}/report/{format} — Generate report (fda/soup/vuln)
• GET /api/v1/audit — Audit trail

Interactive docs at: http://localhost:8000/docs

Docker

# CLI mode
docker run --rm -v $(pwd):/data medsbom check /data/my-sbom.json

# API mode
docker compose -f docker/docker-compose.yml up

Configuration

Environment Variable	Description	Default
NVD_API_KEY	NVD API key (recommended — 10x faster)	None
MEDSBOM_CACHE_DIR	Local cache directory	~/.medsbom/cache
MEDSBOM_AUDIT_DB	Audit database path	~/.medsbom/audit.db

Get a free NVD API key: https://nvd.nist.gov/developers/request-an-api-key

Important Disclaimer

⚠️ REGULATORY NOTICE: MedSBOM generates DRAFT compliance documentation to assist with FDA/IEC-62304 workflows. This tool does NOT constitute legal or regulatory advice. All generated output must be reviewed and approved by a qualified regulatory professional before submission to any regulatory body. MedSBOM contributors accept no liability for regulatory decisions made based on this output.

Project Structure

medsbom/
├── cli/               # Typer CLI
├── core/
│   ├── ingest.py      # SBOM parsing (CycloneDX + SPDX)
│   ├── cve_match.py   # NVD + KEV vulnerability matching
│   ├── eol_check.py   # End-of-life checking
│   ├── risk_score.py  # Composite risk scoring
│   ├── doc_generator.py  # Jinja2 → Markdown/PDF
│   ├── audit.py       # Append-only audit trail
│   └── models.py      # Pydantic data models
├── api/               # FastAPI REST API
├── templates/         # Jinja2 regulatory doc templates
├── tests/             # Comprehensive test suite
├── examples/          # Sample SBOMs and usage guides
└── docker/            # Container deployment

Contributing

We welcome contributions! See CONTRIBUTING.md for guidelines.

Especially welcome:

• Regulatory template improvements (FDA, IEC 62304, ISO 14971, EU MDR)
• Additional SBOM format support
• Integration with more scanners
• Translations of templates

Sponsor

MedSBOM is free and open source. If it saves your team time and money, consider supporting development:

• GitHub Sponsors — Monthly or one-time support
• Open Collective — Transparent community funding
• Buy Me a Coffee — Quick one-time tips

For enterprise support contracts or custom template development, open an issue or email the maintainers.

License

Apache License 2.0 — see LICENSE.

Chosen specifically for medical device companies: permissive, includes patent grant, no copyleft concerns for proprietary firmware integration.

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Built for the medical device community. Free forever.

If MedSBOM helps your team, star the repo and tell your colleagues.