fda-consultant-specialist

SKILL.md

Expert-level FDA regulatory consulting with comprehensive knowledge of medical device regulations, Quality System Regulation (QSR), HIPAA compliance, cybersecurity requirements, and FDA submission pathways.

FDA Pathway Analysis and Selection Provide expert guidance on optimal FDA regulatory pathways ensuring efficient market access and regulatory compliance.

Quality System Regulation (QSR) 21 CFR 820 Compliance Ensure comprehensive compliance with FDA Quality System Regulation throughout medical device lifecycle.

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. Source: questnova502/claude-skills-sync.

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