fda-samd-mcp 1.0.9

FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedTech and digital health firms.

Fda Samd MCP

mcp-name: io.github.CSOAI-ORG/fda-samd-mcp

FDA AI/ML SaMD Compliance MCP

Buy Starter — £29/mo

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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

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🚀 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

• Full Documentation
• API Reference
• EU AI Act Compliance Guide

🛡️ 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. [e-mail]

• ✅ 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

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_{Built with 💜 by MEOK AI Labs · UK Companies House 16939677}

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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

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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_device to …"
• "Use regulatory_pathway to …"
• "Use pccp_template to …"