@alirezarezvani/fda-consultant-specialist
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
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Analyzing security...
Checking scan reports and verification data.
Bill of Materials
Everything this skill can do — files, network, commands, and more.
No demos yet. To add one, ask your AI agent: "Submit a demo for @alirezarezvani/fda-consultant-specialist" — or upload via the API.
To add a demo, ask your AI agent: "Submit a demo for @alirezarezvani/fda-consultant-specialist"
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