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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, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device
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fda-consultant-specialist
skill:alirezarezvani/claude-skills/fda-consultant-specialist · published by alirezarezvani · source repository