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

80%

Does it follow best practices?

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Adds up to 20 points to the overall score

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Securityby

Passed

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tessl review fix ./bundled/skills/iso-13485-certification/SKILL.md

Quality

Content

60%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.

A thorough, well-structured, actionable skill body that makes good use of bundled references, scripts, and templates. Its main weakness is verbosity: substantial content Claude already knows is inlined rather than delegated to the reference files.

Suggestions

Move the full '31 Required Documented Procedures' list, the per-region regulatory summary, and the document retention periods into a reference file and summarize them in SKILL.md to reduce verbosity.

Trim generic best-practice guidance ('Avoid jargon', 'Clear responsibilities', 'Realistic timeframes') that Claude already knows, keeping only domain-specific advice.

Add an explicit validate-and-retry feedback loop around the gap_analyzer.py run (e.g., re-run after addressing missing documents) to strengthen workflow clarity for batch operations.

Dimension	Reasoning	Score
Conciseness	At ~670 lines the body is noticeably verbose, restating domain knowledge Claude already knows (the full 31-procedure list, per-region regulatory summaries, document retention periods) and padded with generic best-practice advice like 'Avoid jargon' and 'Clear responsibilities'.	2 / 5
Actionability	Provides an executable command ('python scripts/gap_analyzer.py --docs-dir ... --output gap-report.json'), concrete template paths, explicit placeholder lists, and validation checklists — concrete guidance with only minor gaps.	4 / 5
Workflow Clarity	Multi-step processes are clearly sequenced with explicit checkpoints and checklists (Quality Manual validation checklist, pre-audit checklist, gap-analysis review steps); minor gaps in explicit feedback loops for the few destructive/batch operations.	4 / 5
Progressive Disclosure	Body is a clear overview with well-signaled one-level-deep references to four real reference files, one script, and three real templates; minor organization gap because the 31-procedure list and regulatory/retention summaries that belong in references are inlined.	4 / 5
	Total	14 / 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.

A strong, specific description that clearly states what the skill does and when to use it, with natural trigger terms and low conflict risk. Third-person voice is maintained throughout.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete actions — 'conducting gap analysis', 'creating Quality Manuals', 'developing required procedures', 'preparing Medical Device Files', 'identifying missing documentation' — with comprehensive coverage of the skill's capabilities.	5 / 5
Completeness	Explicitly answers both 'what' (a comprehensive toolkit for ISO 13485 certification documentation) and 'when' via a 'Use when...' clause with six numbered triggers plus an additional 'Also use when...' clause.	5 / 5
Trigger Term Quality	Natural terms users would say are well covered including 'ISO 13485', 'QMS documentation', 'medical device regulations', 'QMS certification', 'FDA QMSR', and 'EU MDR'.	5 / 5
Distinctiveness Conflict Risk	Targets a clear niche (ISO 13485 medical device QMS certification) with distinct, domain-specific triggers that are unlikely to conflict with other skills.	5 / 5
	Total	20 / 20 Passed

Validation

81%

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 — 13 / 16 Passed

Validation for skill structure

Criteria	Description	Result
skill_md_line_count	SKILL.md is long (678 lines); consider splitting into references/ and linking	Warning
metadata_version	'metadata.version' is missing	Warning
referenced_paths_exist	Referenced path issues: 5 deeper-than-1-level	Warning

	Total	13 / 16 Passed

Repository: foryourhealth111-pixel/Vibe-Skills
Path: bundled/skills/iso-13485-certification/SKILL.md
Commit: d5ae560

Reviewed: 1 day ago

Table of Contents

Discovery Implementation Validation

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