fda-consultant-specialist
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.
Third-Party Agent Skill: Review the code before installing. Agent skills execute in your AI assistant's environment and can access your files. Learn more about security
Installation for Agentic Skill
View all platforms →skilz install alirezarezvani/claude-skills/fda-consultant-specialistskilz install alirezarezvani/claude-skills/fda-consultant-specialist --agent opencodeskilz install alirezarezvani/claude-skills/fda-consultant-specialist --agent codexskilz install alirezarezvani/claude-skills/fda-consultant-specialist --agent geminiFirst time? Install Skilz: pip install skilz
Works with 22+ AI coding assistants
Cursor, Aider, Copilot, Windsurf, Qwen, Kimi, and more...
Extract and copy to ~/.claude/skills/ then restart Claude Desktop
git clone https://github.com/alirezarezvani/claude-skillscp -r claude-skills/ra-qm-team/fda-consultant-specialist ~/.claude/skills/Need detailed installation help? Check our platform-specific guides:
Related Agentic Skills
automating-mail
by SpillwaveSolutions
Automates Apple Mail via JXA with AppleScript dictionary discovery. Use when asked to "automate email", "send mail via script", "JXA Mail automatio...
automating-reminders
by SpillwaveSolutions
Automates Apple Reminders using JavaScript for Automation (JXA). Use when asked to "create reminders programmatically", "automate reminder lists", ...
mastering-postgresql
by SpillwaveSolutions
PostgreSQL development for Python with full-text search (tsvector, tsquery, BM25 via pg_search), vector similarity (pgvector with HNSW/IVFFlat), JS...
automating-contacts
by SpillwaveSolutions
Automates macOS Contacts via JXA with AppleScript dictionary discovery. Use when asked to "automate contacts", "JXA contacts automation", "macOS ad...
Agentic Skill Details
- Owner
- alirezarezvani (GitHub)
- 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
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
Report Security Issue
Found a security vulnerability in this agent skill?
Report Security Issue
Thank you for helping keep SkillzWave secure. We'll review your report and take appropriate action.
Note: For critical security issues that require immediate attention, please also email security@skillzwave.ai directly.