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FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...
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FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...
Security Report
3.8
Use Caution3.8High RiskThis FDA compliance MCP server is architecturally sound with reasonable authentication controls and rate limiting for free-tier users. However, several code quality and security concerns lower the score: the server attempts to load a shared auth module from a hardcoded home directory path with a silent fallback, the upsell decorator dynamically modifies tool behavior in ways that could mask errors, the database location resolution uses multiple fallback paths that may load unverified DBs, and environment variable handling for API keys could be more explicit. The permissions are appropriate for the stated purpose (compliance lookup and regulatory data queries), but the implementation has brittleness that should be addressed. Supply chain analysis found 3 known vulnerabilities in dependencies (0 critical, 3 high severity). Package verification found 1 issue.
4 files analyzed · 12 issues found
Security scores are indicators to help you make informed decisions, not guarantees. Always review permissions before connecting any MCP server.
Permissions Required
This plugin requests these system permissions. Most are normal for its category.
How to Install
Add this to your MCP configuration file:
{
"mcpServers": {
"io-github-csoai-org-fda-samd-mcp": {
"args": [
"fda-samd-mcp"
],
"command": "uvx"
}
}
}Documentation
View on GitHubFrom the project's GitHub README.
Fda Samd MCP
FDA AI/ML SaMD Compliance MCP
Buy Starter — £29/mo
Signed attestations + unlimited audits + email support. 👉 Subscribe at meok.ai — instant HMAC signing key + Stripe-managed billing.
Free tier remains MIT-licensed and zero-config. Upgrade only when you need signed compliance artefacts for audit.
FDA AI/ML SaMD compliance MCP
FDA AI/ML SaMD compliance MCP. 510(k), De Novo, PMA, PCCP, GMLP. MIT
🚀 Quick Start
# Install via pip
pip install fda_samd_mcp
# Or install via Smithery
npx -y @smithery/cli@latest install fda-samd-mcp --client claude
✨ Features
- MCP protocol compliant
- Easy installation
- Well-documented API
- Production-ready
- Active maintenance
📖 Documentation
🛡️ Compliance
This MCP server is built with EU AI Act compliance built-in:
-
Free: 10 calls/day. No API key required.
-
Pro £79/mo: unlimited + signed attestations. Subscribe
-
Enterprise £1,499/mo: white-label + on-premise + SLA. hello@meok.ai
-
✅ Article 9 — Risk Management System
-
✅ Article 13 — Transparency & Instructions for Use
-
✅ Article 15 — Bias Detection & Testing
-
✅ Article 26 — FRIA Support (where applicable)
-
✅ Article 50 — AI Content Watermarking (where applicable)
Need help getting compliant? Book a free 15-min diagnostic →
🏢 Enterprise
Need custom development, SLA guarantees, or white-label deployment?
- Pro: $99/mo — Full MCP suite + EU AI Act tracking
- Enterprise: $499/mo — Custom dev + SLA + Dedicated support
View Pricing → | Contact Sales →
🤝 Part of the MEOK Ecosystem
This server is part of the MEOK AI Labs ecosystem — 300+ MCP servers for sovereign AI governance.
| Domain | Purpose |
|---|---|
| councilof.ai | EU AI Act compliance marketplace |
| safetyof.ai | AI safety & monitoring |
| meok.ai | Sovereign AI platform |
| cobolbridge.ai | Legacy modernization |
📜 License
MIT © CSOAI-ORG
💸 Try MEOK in 30 seconds — instant buy ladder
| Tier | Price | What you get | Stripe |
|---|---|---|---|
| Smoke test | £1 | Signed sample MCP-Hardening report + Article 50 PDF | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
| Quick Kit | £9 | EU AI Act Article 50 implementation guide (C2PA + EU-Icon) | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
| Founder Call | £29 | 30-min 1-on-1 with the founder | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
Refundable. UK Stripe — VAT-clean. Builds on the 81-MCP MEOK fleet. Verify any signed report at https://meok.ai/verify.
Configuration
Add to your claude_desktop_config.json (Claude Desktop) or your MCP client config:
{
"mcpServers": {
"fda-samd-mcp": {
"command": "uvx",
"args": ["fda-samd-mcp"]
}
}
}
Or: pip install fda-samd-mcp then run the fda-samd-mcp command (stdio transport).
Examples
Once configured, ask your assistant, for example:
- "Use
classify_sw_deviceto …" - "Use
regulatory_pathwayto …" - "Use
pccp_templateto …"
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