Guide medical device companies through FDA submission pathways (510(k), PMA, De Novo), QSR compliance, HIPAA requirements, and cybersecurity standards.
/plugin install fda-medical-device-regulatory-consultant@alirezarezvaniRequires Claude Code CLI.
Medical device manufacturers and regulatory affairs professionals use this to select appropriate FDA pathways, prepare compliant submissions, and understand QSR/HIPAA/cybersecurity requirements without external counsel.
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