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fda-consultant-specialist

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FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

When to use

• 510(k) pathway guidance
• PMA pathway guidance
• De Novo pathway guidance
• QSR (21 CFR 820) compliance
• HIPAA assessments
• device cybersecurity
• FDA submission
• predicate device identification

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