FDA SaMD MCP

Software as a Medical Device. IMDRF risk + 510(k) + De Novo + PMA routing.

Install

# Option 1 — uvx (no install)
uvx fda-samd-mcp

# Option 2 — pip
pip install fda-samd-mcp

# Option 3 — npx meok-setup install (recommended)
npx meok-setup --pack industry

What it does

✓IMDRF risk categorisation
✓510(k) substantial equivalence
✓De Novo + PMA routing
✓Quality System Regulation

Claude Desktop config

{
  "mcpServers": {
    "fda-samd": {
      "command": "uvx",
      "args": ["fda-samd-mcp"]
    }
  }
}

Part of the MEOK governance MCP suite — see all 38 servers

MIT licensed · HMAC-signed attestations · Built by MEOK AI Labs