Fda Consultant Specialist

Fda Consultant Specialist

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 cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical devic

Optimized workflow

This edition turns the source methodology into a repeatable agent workflow with explicit inputs, checkpoints and deliverables.

Quality standard

• Confirm scope and missing inputs before execution
• Ground decisions in available evidence and preserve source constraints
• Return an actionable result with assumptions, risks and next steps

Agent compatibility

The same core method is packaged for Claude, Codex, GPT, Gemini, Cursor and OpenCode.