fda-consultant-specialist

579 stars 112 forks
0
F

Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.

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#claude-ai#claudecode-subagents#QSR compliance#claude-ai-skills#FDA requirements#FDA guidance#claude-skills#FDA regulatory

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Installation for Agentic Skill

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skilz install alirezarezvani/claude-skills/fda-consultant-specialist
skilz install alirezarezvani/claude-skills/fda-consultant-specialist --agent opencode
skilz install alirezarezvani/claude-skills/fda-consultant-specialist --agent codex
skilz install alirezarezvani/claude-skills/fda-consultant-specialist --agent gemini

First time? Install Skilz: pip install skilz

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Extract and copy to ~/.claude/skills/ then restart Claude Desktop

1. Clone the repository:
git clone https://github.com/alirezarezvani/claude-skills
2. Copy the agent skill directory:
cp -r claude-skills/ra-qm-team/fda-consultant-specialist ~/.claude/skills/

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Agentic Skill Details

Repository
claude-skills
Stars
579
Forks
112
Type
Other
Meta-Domain
Primary Domain
Market Score
0

Agent Skill Grade

F
Score: 58/100 Click to see breakdown

Score Breakdown

Spec Compliance
12/15
PDA Architecture
13/30
Ease of Use
15/25
Writing Style
4/10
Utility
11/20
Modifiers: +3

Areas to Improve

  • Missing Reference Files
  • Marketing Language
  • Verbose Token Usage

Recommendations

  • Focus on improving Pda (currently 13/30)
  • Focus on improving Writing Style (currently 4/10)
  • Focus on improving Utility (currently 11/20)

Graded: 2026-01-24

Developer Feedback

I took a look at your FDA consultant skill and noticed the grading framework focuses heavily on regulatory compliance patterns—but I'm curious whether the skill documentation assumes users already know which FDA workflows they're targeting, or if it guides them through that discovery first.

Links:

The TL;DR

You're at 58/100, which lands in F territory. This is based on Anthropic's best practices for skill architecture. Your strongest area is Spec Compliance (12/15)—the frontmatter and naming conventions are solid. The real drag is Writing Style (4/10) and Progressive Disclosure Architecture (13/30)—lots of marketing fluff and missing reference files are eating your score.

What's Working Well

  • Valid YAML structure — Your frontmatter is clean and follows conventions properly
  • Good trigger identification — You nailed the discovery terms: "FDA submission", "QSR compliance", "HIPAA" are all solid FDA-specific triggers
  • Structured sections — The skill has clear headers and navigation signals that help users find what they need
  • Addresses real problems — FDA compliance is genuinely useful, and your workflows target actual regulatory pain points

The Big One: Missing Reference Architecture

Here's the problem: Your SKILL.md references 9+ files that don't exist (fda-capa-requirements.md, device-cybersecurity-guidance.md, software-hipaa-compliance.md, etc.), but only a placeholder file actually exists in the references directory. This is a -7 point hit because it breaks Progressive Disclosure Architecture—users click expecting detailed guidance and find nothing.

Fix: Either (1) create all referenced files with actual content—QSR requirements,...

AI-Detected Topics

Extracted using NLP analysis

claude-ai claudecode-subagents QSR compliance claude-ai-skills FDA requirements FDA guidance claude-skills FDA regulatory compliance claude-code

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