Fda Consultant Specialist

Handles FDA regulatory questions for medical device companies, walking through 510(k) versus PMA pathway decisions, QSR compliance checklists, and device cybersecurity requirements. Includes decision trees for predicate device searches, substantial equivalence comparisons, and design control workflows per 21 CFR 820.30. Also covers HIPAA applicability for connected devices and premarket cybersecurity documentation. Best for companies preparing submissions or navigating FDA requirements, though you'll still need a regulatory consultant for final review. The structured tables and workflows are genuinely useful as quick references during early planning phases.

Install to Claude Code

npx -y skills add borghei/claude-skills --skill fda-consultant-specialist --agent claude-code