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fda-samd-mcp

fda-samd-mcp

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github.com/CSOAI-ORGLegal & Government1Updated 18w ago
Repository

About fda-samd-mcp

fda-samd-mcp is an MCP server for FDA compliance work on AI/ML Software as a Medical Device. It covers 510(k), De Novo, PMA, PCCP, and GMLP pathways for teams assessing medical-device software regulation.

Key features

  1. 01510(k) pathway support
  2. 02De Novo pathway support
  3. 03PMA pathway support
  4. 04PCCP support
  5. 05GMLP coverage

Use cases

  1. 01Classify software as a medical device
  2. 02Identify a regulatory pathway
  3. 03Prepare a PCCP template

MCP support

It exposes FDA AI/ML SaMD compliance tools to MCP clients, including classify_sw_device, regulatory_pathway, and pccp_template.

Configuration

Local server config is the same for every client. Copy it into your client’s MCP config file.

mcp.json · Universal config
{
  "mcpServers": {
    "csoai-org-fda-samd": {
      "command": "uvx",
      "args": [
        "fda-samd-mcp"
      ]
    }
  }
}
Run commanduvx fda-samd-mcp

Local servers need a runtime on your machine (e.g. Node.js 18+). Config file locations differ by client; see your client’s docs.

Packages
pypifda-samd-mcp1.0.11

Tools

No tool list yet

Local servers expose tools only once running on your machine, and the maintainer has not provided a tool list.

Details

From the project README

MCP Scorecard: 90/100

Fda Samd MCP

MEOK AI Labs EU AI Act License PyPI mcp-name: io.github.CSOAI-ORG/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.

PyPI License: MIT MEOK AI Labs

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. [email protected]

  • ✅ 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.

DomainPurpose
councilof.aiEU AI Act compliance marketplace
safetyof.aiAI safety & monitoring
meok.aiSovereign AI platform
cobolbridge.aiLegacy modernization

📜 License

MIT © CSOAI-ORG

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

💸 Try MEOK in 30 seconds — instant buy ladder

TierPriceWhat you getStripe
Smoke test£1Signed sample MCP-Hardening report + Article 50 PDFhttps://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t
Quick Kit£9EU AI Act Article 50 implementation guide (C2PA + EU-Icon)https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t
Founder Call£2930-min 1-on-1 with the founderhttps://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_device to …"
  • "Use regulatory_pathway to …"
  • "Use pccp_template to …"

Comments

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