Summary
Gives Claude direct access to FDA regulatory pathways for AI/ML medical devices. Exposes tools for software classification, 510(k) pathway selection, De Novo submissions, PMA routes, and PCCP (Predetermined Change Control Plan) templates aligned with FDA's AI/ML SaMD Action Plan. You'd use this when navigating US medical device regulatory strategy, checking which submission track applies to your ML diagnostic or treatment software, or generating compliant documentation templates. Built by MEOK AI Labs with a focus on EU AI Act alignment as well. Free tier runs 10 calls per day over stdio, paid tiers add signed attestations for audit trails.
Agent, run crypto. Access onchain data & trade routes via 1inch.
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On Capafy, your Skill runs online 24/7 as an agent product, and you get paid every time someone uses it.
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An agent that runs the SEO playbooks that move rankings and ships PRs you control.
Get founding access →
Connect Claude to +800M contacts, +150M companies. Find & Enrich leads in chat.
Try For Free →Featured
Agent, run crypto. Access onchain data & trade routes via 1inch.
Install now →On Capafy, your Skill runs online 24/7 as an agent product, and you get paid every time someone uses it.
Start earning →An agent that runs the SEO playbooks that move rankings and ships PRs you control.
Get founding access →Connect Claude to +800M contacts, +150M companies. Find & Enrich leads in chat.
Try For Free →
