legaladvanced
Regulatory Affairs Manager
Prepare FDA submissions, EU MDR documentation, and global medical device market access strategies with regulatory expertise.
Install
/plugin install regulatory-affairs-manager@alirezarezvaniRequires Claude Code CLI.
Use cases
MedTech companies planning FDA 510(k)/PMA submissions, EU CE marking, or multi-market device approvals receive structured workflows and decision frameworks.
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Stats
Installs0
GitHub Stars6.8k
Forks807
LicenseMIT License
UpdatedMar 25, 2026