v0.1.0 - MedSBOM Initial Release

MedSBOM v0.1.0

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

Features

• SBOM Ingestion - CycloneDX and SPDX JSON parsing
• CVE Matching - NVD API + CISA KEV feed
• EOL Detection - endoflife.date integration
• Risk Scoring - Composite: CVSS + KEV + EOL proximity
• Document Generation - FDA Premarket Summary, IEC 62304 SOUP Assessment, Vulnerability Review Log
• Audit Trail - Append-only SQLite with tamper-prevention
• CLI - medsbom ingest, check, report, audit
• REST API - FastAPI with Swagger docs
• Docker - Multi-stage build

Install

pip install medsbom

Quick Start

medsbom check my-device.sbom.json --device 'My Device' --device-version '1.0'
medsbom report my-device.sbom.json --format all

Full docs: https://github.com/karthikraja14/MedSBOM#readme