Expert guidance and best practices (Database + Data-analysis)
Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.
Core Features
Ready to Use
Quick integration into your workflow with minimal setup
Community Verified
Active open-source community with continuous updates
Completely Free
MIT/Apache licensed for commercial and personal use
Flexible Extension
Customizable and extendable based on your needs
How to Use
2Install to Claude
Place the skill file in Claude's skills directory (usually ~/.claude/skills/）。
3Start Using
Restart Claude or run the reload command to load the skill
Tip: Read the documentation and code carefully before first use to understand functionality and permission requirements
Related Tags
Technical Information
All Skills from open-source community, preserving original authors' copyrights
alirezarezvani__claude-skills/ra-qm-team/fda-consultant-specialist/skill.mdRelated Skills
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