fda-consultant-specialist
From the author
FDA regulatory consultant for medical device companies, covering 510(k)/PMA/De Novo pathways, QSR (21 CFR 820), HIPAA, and device cybersecurity. Use for FDA submissions, predicate and substantial-equivalence analysis, and premarket strategy.
Install
npx skills add borghei/Claude-Skills --skill fda-consultant-specialist -a claude-code
Installs to .claude/skills/fda-consultant-specialist/ · Each command fetches the skill straight from GitHub with the open skills CLI.
No download: this skill’s licence (Custom or unclear) does not let us redistribute its files. The install commands fetch them from GitHub instead.
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- Ships scripts we have not reviewedLow
Why 76
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