MCP server for FDA data: drug approvals, recalls, adverse events, 510(k) device clearances. Wraps openFDA.
Orthopedic and spine FDA 510(k) clearance reports with direct source links and applicant history.
Hash-chained, append-only record schema + reference verifier for an AI/ML medical device's FDA SaMD classification lifecycle — pre-submission through 510(k)/De Novo/PMA, PCCP per FDA Dec 2024 final, post-market modifications, 21 CFR §820 QMS evidence refs. Healthcare-readiness scaffolding, not certification.
Fillable PDF — three practitioner templates with live checkboxes, dropdowns, and text fields
Focused tools and source-linked research from Mark Signals.
RAPath Global Hub - Medical Device Regulatory Reference in Plain English. Properly sourced.
A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.
Add a description, image, and links to the 510k topic page so that developers can more easily learn about it.
To associate your repository with the 510k topic, visit your repo's landing page and select "manage topics."