mdr-745-specialist
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.
Install with Tessl CLI
npx tessl i github:alirezarezvani/claude-skills --skill mdr-745-specialistOverall
score
83%
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npx tessl skill review --optimize ./path/to/skillValidation for skill structure
Discovery
100%Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.
This is a well-crafted skill description that excels across all dimensions. It provides specific concrete actions, uses natural domain terminology that regulatory professionals would search for, explicitly states both capabilities and usage triggers, and occupies a clear regulatory niche that won't conflict with other skills.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: 'gap analysis', 'technical documentation guidance', 'clinical evidence requirements', 'post-market surveillance implementation', 'classification decisions', 'technical file preparation', 'regulatory requirement interpretation'. | 3 / 3 |
Completeness | Clearly answers both what (MDR compliance expertise, gap analysis, documentation guidance, etc.) AND when ('Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation'). | 3 / 3 |
Trigger Term Quality | Includes strong natural keywords users would say: 'MDR', 'EU MDR 2017/745', 'medical device', 'compliance', 'technical file', 'classification', 'post-market surveillance', 'clinical evidence'. These are terms regulatory professionals naturally use. | 3 / 3 |
Distinctiveness Conflict Risk | Highly specific niche targeting EU MDR 2017/745 medical device regulations. The specific regulation reference and domain-specific terminology make it very unlikely to conflict with other skills. | 3 / 3 |
Total | 12 / 12 Passed |
Implementation
70%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This skill provides a comprehensive structural framework for MDR compliance consulting with excellent workflow organization and progressive disclosure. However, it lacks concrete executable examples and actionable code snippets, relying instead on references to scripts that aren't shown. The content could be more concise by removing introductory fluff and trusting Claude's baseline regulatory knowledge.
Suggestions
Add executable code examples for at least one referenced script (e.g., show actual usage of mdr-gap-analysis.py with sample input/output)
Remove the introductory paragraph describing Claude's expertise - this is unnecessary self-description
Include a concrete example of a classification decision with specific device characteristics and the resulting classification rationale
Add sample output formats for key deliverables like gap analysis reports or PSUR summaries
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | The content is reasonably organized but includes some verbose explanations and structural overhead that could be tightened. Phrases like 'Expert-level EU MDR 2017/745 compliance specialist with comprehensive knowledge' add little value, and some sections repeat concepts Claude would already understand about regulatory frameworks. | 2 / 3 |
Actionability | The skill provides structured frameworks and decision points but lacks concrete, executable examples. The referenced scripts (mdr-gap-analysis.py, etc.) are listed but no actual code or command examples are provided. Guidance remains at the procedural description level rather than copy-paste ready instructions. | 2 / 3 |
Workflow Clarity | Multi-step processes are clearly sequenced with numbered steps and explicit decision points marked throughout (e.g., 'Decision Point: Determine appropriate classification class'). The workflows for classification, clinical evidence pathways, and Notified Body engagement include clear checkpoints and branching logic. | 3 / 3 |
Progressive Disclosure | Content is well-organized with clear section hierarchy and appropriate references to external files (references/, scripts/, assets/). The main skill provides an overview while pointing to detailed resources like 'mdr-classification-guide.md' and 'technical-documentation-templates.md' for deeper information. | 3 / 3 |
Total | 10 / 12 Passed |
Validation
75%Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.
Validation — 12 / 16 Passed
Validation for skill structure
| Criteria | Description | Result |
|---|---|---|
description_trigger_hint | Description may be missing an explicit 'when to use' trigger hint (e.g., 'Use when...') | Warning |
metadata_version | 'metadata' field is not a dictionary | Warning |
license_field | 'license' field is missing | Warning |
body_output_format | No obvious output/return/format terms detected; consider specifying expected outputs | Warning |
Total | 12 / 16 Passed | |
- Reviewed
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