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.
8.1
Rating
0
Installs
Business & Productivity
Category
Excellent FDA regulatory consulting skill with comprehensive coverage of medical device pathways, QSR compliance, HIPAA requirements, and cybersecurity guidance. The description clearly indicates when to use this skill (FDA submission planning, compliance assessments, regulatory strategy). The SKILL.md provides extensive task knowledge including detailed frameworks for 510(k)/PMA submissions, QSR compliance checklists, HIPAA safeguards, and cybersecurity requirements. Structure is well-organized with clear hierarchies and decision trees, though the main file is quite detailed. References to external files (scripts/, references/, assets/) are appropriately used for supporting materials. The skill demonstrates high novelty by consolidating specialized FDA regulatory expertise that would require extensive research and domain knowledge for a CLI agent to replicate, involving complex compliance frameworks, regulatory pathways, and industry-specific terminology. Minor improvement areas: could benefit from more explicit decision-making guidance and slightly more modular organization to prevent the main SKILL.md from becoming too dense.
davila7
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