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Search FDA Submissions , found 2 results

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FDA Device Regulatory Guide

fda-consultant-specialist

alirezarezvani/claude-skills

Provides FDA regulatory guidance for medical device manufacturers encompassing pathway strategy for 510(k)/PMA/De Novo submissions, QSR compliance, HIPAA assessments, and cybersecurity planning to support premarket filings.

Medical Device Regulatory Lead

regulatory-affairs-head

alirezarezvani/claude-skills

Provides senior regulatory affairs guidance for HealthTech and MedTech firms, driving FDA 510(k)/De Novo/PMA submissions, CE marking, and multi-market access strategies while maintaining intelligence on evolving regulations.

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