其他

fda-consultant-specialist

Name: fda-consultant-specialist
Author: alirezarezvani

alirezarezvani/…e-skills

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 device, or FDA cybersecurity.

778 次安装
2.9万星标
收录于 2026.01.20

安装命令

$ npx skills add https://github.com/alirezarezvani/claude-skills --skill fda-consultant-specialist

SKILL.md

FDA Consultant Specialist

FDA regulatory consulting for medical device manufacturers covering submission pathways, the Quality Management System Regulation (QMSR, 21 CFR Part 820 — formerly the QSR), HIPAA compliance, and device cybersecurity requirements.

FDA Pathway Selection
510(k) Submission Process
QMSR Compliance (formerly QSR)
HIPAA for Medical Devices
Device Cybersecurity
Resources

FDA Pathway Selection

Determine the appropriate FDA regulatory pathway based on device classification and predicate availability.

SKILL.md

FDA Consultant Specialist

Table of Contents

FDA Pathway Selection

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