iso-13485-certification
tessl i github:K-Dense-AI/claude-scientific-skills --skill iso-13485-certificationComprehensive 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.
Review Score
68%
Validation Score
14/16
Implementation Score
35%
Activation Score
100%
Generated
Validation
Total
14/16Score
Passed| Criteria | Score |
|---|---|
skill_md_line_count | SKILL.md is long (680 lines); consider splitting into references/ and linking |
metadata_version | 'metadata.version' is missing |
Implementation
Suggestions 4
Score
35%Overall Assessment
This skill attempts to be comprehensive but sacrifices usability for completeness. The content is excessively verbose, repeating information across sections and explaining concepts Claude already understands. While it references useful external resources, the main document should be a concise overview pointing to those resources rather than duplicating their content inline.
Suggestions
- Reduce content by 60-70% by moving detailed scenarios, best practices, and quick reference sections to separate files, keeping only a concise overview with clear navigation links
- Remove explanatory content about what ISO 13485 is, what procedures are, and other concepts Claude already knows - focus only on project-specific guidance
- Add explicit validation checkpoints to workflows, especially for document creation (e.g., 'Validate: Run python scripts/validate_procedure.py before proceeding')
- Include at least one concrete, executable example inline (e.g., actual gap analysis output format, actual template snippet) rather than only referencing external files
| Dimension | Score | Reasoning |
|---|---|---|
Conciseness | 1/3 | Extremely verbose at 700+ lines with significant redundancy. Explains concepts Claude knows (what a QMS is, what procedures are), repeats the same information multiple times (priority lists appear twice, scenarios duplicate workflow content), and includes excessive context that doesn't add actionable value. |
Actionability | 2/3 | Provides some concrete guidance with script commands and file paths, but most content is descriptive rather than executable. Templates are referenced but not shown inline, and many sections describe what to do abstractly rather than providing copy-paste ready examples or specific commands. |
Workflow Clarity | 2/3 | Multi-step processes are listed but lack explicit validation checkpoints. The gap analysis workflow mentions running a script and reviewing results but doesn't include error handling or verification steps. Document creation workflows list phases but don't include feedback loops for catching errors. |
Progressive Disclosure | 2/3 | References external files appropriately (references/, templates/, scripts/) but the main document is a monolithic wall of text. Content that should be in separate files (detailed scenarios, best practices, quick reference lists) is inline, making the skill overwhelming rather than scannable. |
Activation
Score
100%Overall Assessment
This is an excellent skill description that clearly articulates specific capabilities, provides comprehensive trigger terms covering both ISO standards and related regulations, and explicitly states when to use the skill with a numbered list of scenarios. The description is well-structured, uses appropriate third-person voice, and carves out a distinct niche in medical device quality management documentation.
| Dimension | Score | Reasoning |
|---|---|---|
Specificity | 3/3 | Lists multiple specific concrete actions: conducting gap analysis, creating Quality Manuals, developing procedures and work instructions, preparing Medical Device Files, understanding requirements, and identifying missing documentation. |
Completeness | 3/3 | Clearly answers both what (comprehensive toolkit for preparing ISO 13485 certification documentation) and when (explicit 'Use when' clause with numbered scenarios plus additional trigger terms like FDA QMSR, EU MDR). |
Trigger Term Quality | 3/3 | 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'. |
Distinctiveness Conflict Risk | 3/3 | Highly distinctive niche focused specifically on ISO 13485 medical device QMS documentation with clear regulatory context (FDA QMSR, EU MDR); unlikely to conflict with general documentation or other compliance skills. |