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mdr-745-specialist

579 stars 112 forks
0
D

EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap analysis, technical documentation guidance, clinical evidence requirements, and post-market surveillance implementation. Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation.

CommandsAgentsMarketplace
#clinical evidence#claude-ai#MDR compliance#claudecode-subagents#claude-ai-skills#MDR requirements#requirements#technical documentation

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

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skilz install alirezarezvani/claude-skills/mdr-745-specialist
skilz install alirezarezvani/claude-skills/mdr-745-specialist --agent opencode
skilz install alirezarezvani/claude-skills/mdr-745-specialist --agent codex
skilz install alirezarezvani/claude-skills/mdr-745-specialist --agent gemini

First time? Install Skilz: pip install skilz

Works with 22+ AI coding assistants

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Download Agent Skill ZIP

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/mdr-745-specialist ~/.claude/skills/
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Need detailed installation help? Check our platform-specific guides:

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Agentic Skill Details

Owner
alirezarezvani (GitHub)
Repository
claude-skills
Stars
579
Forks
112
Type
Other
Meta-Domain
Primary Domain
Market Score
0
Agentic Skill Grades →

Agent Skill Grade

D
Score: 68/100 Click to see breakdown

Score Breakdown

Spec Compliance
12/15
PDA Architecture
17/30
Ease of Use
18/25
Writing Style
7/10
Utility
13/20
Modifiers: +1

Areas to Improve

  • Reference files are placeholders
  • Missing concrete examples
  • Marketing language in description

Recommendations

  • Focus on improving Pda (currently 17/30)
  • Address 3 high-severity issues first
  • Add trigger phrases to description for discoverability

Graded: 2026-01-24

Developer Feedback

Found your mdr-745-specialist skill while reviewing the grading pipeline—the approach to specialist routing caught my eye, especially given the 68/100 score suggests some solid fundamentals but room to tighten the architecture. What's driving the focus on MDR-specific handling here?

Links:

The TL;DR

You're at 68/100, solid D-grade territory. The skill has strong fundamentals—your Spec Compliance (12/15) and metadata are legit—but you're losing major points on Progressive Disclosure Architecture (17/30) and Utility (13/20). The core issue: you're front-loading too much detail into SKILL.md when it should be spread across reference files, and your promised implementations (scripts, templates, detailed guides) don't actually exist yet.

What's Working Well

  • Spec Compliance is locked in — Your frontmatter is valid YAML, naming follows conventions perfectly (hyphen-case), and you've got solid trigger phrases like "MDR compliance," "classification," and "technical documentation"
  • Clear workflow structure — The numbered decision trees (Classification Determination, Gap Analysis Framework, Documentation Preparation) show you understand the problem space and have thought through the process
  • Good navigational signals — Even at 196 lines, your headers make it scannable. The "when to use" section is practical

The Big One: Reference Files Are Placeholders

This is eating ~5 points right now. You reference detailed guides (mdr-classification-guide.md, clinical-evidence-requirements.md, technical-documentation-templates.md) throughout SKILL.md, but references/api_reference.md is just a stub:

# Reference Documentation for Mdr 745 Specialist
This is a placeholder for detailed reference docume...

AI-Detected Topics

Extracted using NLP analysis

clinical evidence claude-ai MDR compliance claudecode-subagents claude-ai-skills MDR requirements requirements technical documentation claude-skills clinical

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