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

Official

by CSOAI-ORG · Python

FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...

Tracks FDA regulatory pathways for AI/ML medical device software submissions.

Topics

ai-mlfdamcpmedical-devicemeoksamdai-complianceclaudemcp-servermit-licensemodel-context-protocolopen-sourceai-agentsmeok-ai-labsai-governancecompliancecsoai

Install

claude_desktop_config.json

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