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fda-consultant-specialist

alirezarezvani/claude-skills

FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.

Installs157
Install command
npx skills add https://github.com/alirezarezvani/claude-skills --skill fda-consultant-specialist
Security audits
Gen Agent Trust HubPASS
SocketPASS
SnykPASS
About this skill
FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements. Determine the appropriate FDA regulatory pathway based on device classification and predicate availability. Reference: See fda_submission_guide.md for pathway decision matrices and submission requirements. Quality System Regulation (21 CFR Part 820) requirements for medical device manufacturers. Reference: See qsr_compliance_requirements.md for detailed QSR implementation guidance. HIPAA requirements for devices that create, store, transmit, or access Protected Health Information (PHI). Reference: See hipaa_compliance_framework.md for implementation checklists and BAA templates. FDA cybersecurity requirements for connected medical devices.

Source description provided by the upstream skill listing. Community reviews and install context appear in the sections below.

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FAQ
What does fda-consultant-specialist do?

FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.

Is fda-consultant-specialist good?

fda-consultant-specialist does not have approved reviews yet, so SkillJury cannot publish a community verdict.

What agent does fda-consultant-specialist work with?

fda-consultant-specialist currently lists compatibility with codex, gemini-cli, opencode, cursor, github-copilot, claude-code.

What are alternatives to fda-consultant-specialist?

Skills in the same category include telegram-bot-builder, flutter-app-size, sharp-edges, iterative-retrieval.

How do I install fda-consultant-specialist?

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

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