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.
Install with Tessl CLI
npx tessl i github:K-Dense-AI/claude-scientific-skills --skill iso-13485-certification78
Quality
71%
Does it follow best practices?
Impact
93%
1.45xAverage score across 3 eval scenarios
Optimize this skill with Tessl
npx tessl skill review --optimize ./scientific-skills/iso-13485-certification/SKILL.mdDiscovery
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 exemplary skill description that excels across all dimensions. It provides comprehensive specificity with six enumerated use cases, includes excellent trigger term coverage spanning multiple regulatory frameworks, explicitly addresses both 'what' and 'when' questions, and occupies a clearly distinct niche in medical device quality management documentation.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: 'conducting gap analysis', 'creating Quality Manuals', 'developing required procedures and work instructions', 'preparing Medical Device Files', 'understanding ISO 13485 requirements', 'identifying missing documentation'. Uses proper third person voice throughout. | 3 / 3 |
Completeness | Clearly answers both what (comprehensive toolkit for preparing ISO 13485 certification documentation) and when with explicit 'Use when' clause that enumerates six specific scenarios plus additional trigger conditions for related regulations. | 3 / 3 |
Trigger Term Quality | Excellent coverage of natural terms users would say: 'ISO 13485', 'QMS documentation', 'Quality Manuals', 'Medical Device Files', 'medical device regulations', 'QMS certification', 'FDA QMSR', 'EU MDR', 'quality system documentation'. Includes both formal standards and common variations. | 3 / 3 |
Distinctiveness Conflict Risk | Highly distinctive niche focused specifically on ISO 13485 medical device QMS documentation. The specific regulatory references (FDA QMSR, EU MDR) and medical device focus make it unlikely to conflict with general documentation or other compliance skills. | 3 / 3 |
Total | 12 / 12 Passed |
Implementation
42%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This skill has excellent progressive disclosure with well-organized references to external resources, but suffers from severe verbosity that undermines its utility. The content repeats itself extensively (scenarios largely duplicate the core workflow), explains basic concepts Claude already knows, and provides more descriptive guidance than executable instructions. The workflow clarity is adequate but lacks the explicit validation checkpoints needed for complex documentation processes.
Suggestions
Reduce content by 60-70% by eliminating redundant sections (scenarios repeat workflow content), removing explanations of basic concepts (what QMS is, what procedures are), and consolidating the priority lists that appear multiple times.
Add executable code examples for the gap_analyzer.py script showing actual output format and how to interpret results, rather than just referencing the script path.
Add explicit validation checkpoints with pass/fail criteria in the document creation workflow, such as 'Run validation script and confirm zero errors before proceeding' rather than just 'Validate completeness'.
Convert the verbose scenario sections into a brief decision tree or table that points to the relevant workflow section, rather than repeating the workflow content in each scenario.
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | Extremely verbose at 600+ lines with significant redundancy. Explains concepts Claude already knows (what a QMS is, what procedures are), repeats the same information multiple times (priority lists appear twice, scenarios repeat workflow content), and includes excessive context that doesn't add actionable value. | 1 / 3 |
Actionability | Provides some concrete guidance with script commands and file paths, but much content is descriptive rather than executable. The gap analyzer script is referenced but no actual code shown. Templates are referenced but not inline. Many sections describe what to do conceptually rather than providing copy-paste ready instructions. | 2 / 3 |
Workflow Clarity | Multi-step processes are listed but validation checkpoints are weak. The core workflow has numbered steps but lacks explicit verification gates. For example, document creation process says 'Validate completeness' with a checklist but no automated validation or clear pass/fail criteria. Missing feedback loops for error recovery in critical operations. | 2 / 3 |
Progressive Disclosure | Good structure with clear references to external files (references/, assets/templates/, scripts/). Navigation is well-signaled with specific file paths. Content is appropriately split between overview in SKILL.md and detailed materials in referenced files. One level deep references throughout. | 3 / 3 |
Total | 8 / 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 | |
- Reviewed
Table of Contents
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