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.

Quality

85%

Does it follow best practices?

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Securityby

Passed

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Quality

Content

71%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

The body is well-structured with strong progressive disclosure and genuinely actionable references, but it is noticeably verbose with redundant restatement across the workflow, scenarios, and resource sections. Tightening the repeated content would materially improve token efficiency.

Suggestions

Consolidate the 'Common Scenarios' section: it restates Core Workflow steps that already appear verbatim above — replace with brief cross-references or trim to only the scenario-specific deviation.

Remove the 'Resources' section or fold it into the inline reference lists already present in each workflow step, since the same file pointers appear twice.

Document the gap_analyzer.py flags and expected output inline (next to the command) so users can run it without opening the script, raising actionability toward 5.

Dimension	Reasoning	Score
Conciseness	The ~670-line body restates information in several places — the 'Common Scenarios' section re-walks the Core Workflow steps and the 'Resources' section duplicates the inline file pointers — which is more than minor over-explanation, though it avoids filler about basics Claude already knows.	3 / 5
Actionability	Provides a concrete executable command, real template paths, specific clause references (e.g. 8.5.2/8.5.3), and explicit placeholders ([COMPANY NAME], [DATE]); minor gaps remain because the script's flags/behavior and template internals live in referenced files rather than inline.	4 / 5
Workflow Clarity	The five-stage workflow is clearly sequenced with numbered sub-steps and explicit validation checkpoints (Quality Manual checklist, 'Validate completeness' step, pre-audit checklist); feedback loops are framed as checklists rather than explicit validate-fix-retry cycles, leaving a minor gap.	4 / 5
Progressive Disclosure	SKILL.md is a well-organized overview with clearly signaled, one-level-deep references to 4 reference files, 1 script, and 3 templates — all verified to exist — with no nested references and easy navigation via Resources and Quick Reference sections.	5 / 5
	Total	16 / 20 Passed

Description

100%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

The description is specific, complete, and rich with natural trigger terms, clearly stating both what the skill does and when to use it across a well-scoped regulatory niche. No fluff or over-claims.

Dimension	Reasoning	Score
Specificity	Lists six explicit concrete actions (gap analysis, Quality Manuals, procedures/work instructions, Medical Device Files, understanding requirements, identifying missing documentation), giving comprehensive coverage of the domain.	5 / 5
Completeness	Explicitly answers both 'what' (toolkit for preparing ISO 13485 certification documentation) and 'when' with two concrete trigger clauses ('Use when users need help with...' and 'Also use when users mention...').	5 / 5
Trigger Term Quality	Covers the natural phrases a user would say — 'ISO 13485', 'QMS', 'medical device regulations', 'QMS certification', 'FDA QMSR', 'EU MDR', 'quality system documentation' — including regulatory synonyms and variants.	5 / 5
Distinctiveness Conflict Risk	Occupies a clear niche (ISO 13485 medical-device QMS certification) with distinct, specialized triggers unlikely to fire for unrelated skills.	5 / 5
	Total	20 / 20 Passed

Validation

75%

Warnings & errors only

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
skill_md_line_count	SKILL.md is long (680 lines); consider splitting into references/ and linking	Warning
metadata_version	'metadata.version' is missing	Warning
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning
referenced_paths_exist	Referenced path issues: 5 deeper-than-1-level	Warning

	Total	12 / 16 Passed

Repository: synthetic-sciences/openscience
Path: backend/cli/skills/other/iso-13485-certification/SKILL.md
Commit: 7dabbf0

Reviewed: 3 days ago

Table of Contents

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