FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...
Config is the same across clients — only the file and path differ.
{
"mcpServers": {
"io-github-csoai-org-fda-samd-mcp": {
"command": "<see-readme>",
"args": []
}
}
}Are you the author?
Add this badge to your README to show your security score and help users find safe servers.
FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...
No automated test available for this server. Check the GitHub README for setup instructions.
Five weighted categories — click any category to see the underlying evidence.
No known CVEs.
No package registry to scan.
This server is missing a description. Tools and install config are also missing.If you've used it, help the community.
Add informationBe the first to review
Have you used this server?
Share your experience — it helps other developers decide.
Sign in to write a review.
Others in health
MCP server for the ClinicalTrials.gov v2 API. Search trials, retrieve study details and results, and match patients to eligible trials.
MCP server for Withings health data — sleep, activity, heart, and body metrics.
MCP Server for Brazilian ICD-10 (DATASUS) - International Classification of Diseases
Search and contribute to the Open Food Facts database.
MCP Security Weekly
Get CVE alerts and security updates for io.github.CSOAI-ORG/fda-samd-mcp and similar servers.
Start a conversation
Ask a question, share a tip, or report an issue.
Sign in to join the discussion.
mcp-name: io.github.CSOAI-ORG/fda-samd-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
# Install via pip
pip install fda_samd_mcp
# Or install via Smithery
npx -y @smithery/cli@latest install fda-samd-mcp --client claude
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 →
Need custom development, SLA guarantees, or white-label deployment?
View Pricing → | Contact Sales →
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 |
MIT © CSOAI-ORG
Built with 💜 by MEOK AI Labs · UK Companies House 16939677
| 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