iso-13485-certification
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
76
67%
Does it follow best practices?
Impact
93%
1.45xAverage score across 3 eval scenarios
Passed
No known issues
Optimize this skill with Tessl
npx tessl skill review --optimize ./scientific-skills/iso-13485-certification/SKILL.mdQuality
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 an excellent skill description that clearly defines its scope, lists specific concrete actions, and provides comprehensive trigger guidance. It uses proper third-person voice, includes both a primary 'Use when' clause with enumerated scenarios and a secondary 'Also use when' clause for related terms. The highly specialized domain (ISO 13485 medical device QMS) ensures strong distinctiveness.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: conducting gap analysis, creating Quality Manuals, developing procedures and work instructions, preparing Medical Device Files, understanding ISO 13485 requirements, and identifying missing documentation. | 3 / 3 |
Completeness | Clearly answers both 'what' (comprehensive toolkit for preparing ISO 13485 certification documentation with six enumerated capabilities) and 'when' (explicit 'Use when' clause with detailed trigger scenarios, plus an 'Also use when' clause covering related regulatory terms). | 3 / 3 |
Trigger Term Quality | Excellent coverage of natural terms users would say: 'ISO 13485', 'QMS documentation', 'gap analysis', 'Quality Manuals', 'Medical Device Files', 'medical device regulations', 'QMS certification', 'FDA QMSR', 'EU MDR', 'quality system documentation', and 'medical device certification'. | 3 / 3 |
Distinctiveness Conflict Risk | Highly distinctive niche targeting ISO 13485 medical device QMS documentation specifically. The domain-specific terminology (ISO 13485, FDA QMSR, EU MDR, Medical Device Files) makes it very unlikely to conflict with other skills. | 3 / 3 |
Total | 12 / 12 Passed |
Implementation
35%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This skill is comprehensive in coverage but severely over-verbose, explaining many concepts Claude already understands and repeating workflow steps across multiple sections (core workflow, common scenarios, getting started). The references to external files and templates are well-organized, but the main file tries to be both an overview and a complete manual, resulting in a monolithic document that undermines token efficiency. Actionability is moderate — there are file paths and one script command, but most guidance remains at the descriptive level rather than providing concrete examples of actual document content.
Suggestions
Reduce content by 60%+ by removing explanations of concepts Claude already knows (what an MDF is, general writing advice like 'avoid jargon'), eliminating the redundant Common Scenarios section that largely restates the Core Workflow, and moving regulatory requirements and document retention info to reference files.
Add concrete examples of actual document content — e.g., a sample Quality Policy paragraph, a filled-in CAPA form entry, or a completed exclusion justification — rather than just describing what should be in them.
Move the Quick Reference section (31 procedures list, regulatory requirements, retention periods) and Best Practices to separate reference files, keeping SKILL.md as a concise overview with clear pointers.
Add executable validation steps to the document creation workflow — e.g., a script or checklist command that verifies all placeholders have been replaced and required sections are present, with a fix-and-retry loop.
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | Extremely verbose at ~500+ lines. Extensively explains concepts Claude already knows (what an MDF is, what a Quality Manual is, general document writing best practices like 'clear, simple language' and 'avoid jargon'). The common scenarios section largely repeats the core workflow steps. Much content could be condensed by 60-70%. | 1 / 3 |
Actionability | Provides some concrete guidance like the gap_analyzer.py command and references to specific template files, but most content is procedural description rather than executable instructions. The bulk of the skill describes processes at a high level ('gather organization information', 'customize template') without showing concrete examples of actual output or filled-in content. | 2 / 3 |
Workflow Clarity | Multi-step processes are clearly sequenced with numbered steps and phases, and there are some validation checklists (e.g., Quality Manual validation checklist, pre-audit checklist). However, validation steps are mostly presented as static checklists rather than executable verification commands, and there are no feedback loops for error recovery in the document creation workflows. | 2 / 3 |
Progressive Disclosure | References to external files (references/, templates/, scripts/) are well-signaled and one level deep, which is good. However, the SKILL.md itself is monolithic with enormous amounts of inline content that should be split into separate files — the common scenarios, best practices, quick reference sections, and regulatory requirements could all be separate reference documents. | 2 / 3 |
Total | 7 / 12 Passed |
Validation
81%Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.
Validation — 9 / 11 Passed
Validation for skill structure
| Criteria | Description | Result |
|---|---|---|
skill_md_line_count | SKILL.md is long (679 lines); consider splitting into references/ and linking | Warning |
metadata_version | 'metadata.version' is missing | Warning |
Total | 9 / 11 Passed | |
- Repository
- K-Dense-AI/claude-scientific-skills
- Commit
b58ad7e
- Reviewed
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