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

92%

Does it follow best practices?

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Adds up to 20 points to the overall score

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Securityby

Passed

No findings from the security scan

The canonical home for this skill is iso-13485-certification in K-Dense-AI/scientific-agent-skills

Quality

Content

85%

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

The content is highly actionable, clearly sequenced with validation checkpoints, and well-structured with real one-level-deep references. Its main weakness is verbosity and redundancy between the workflow and scenario sections, which could be consolidated to respect the token budget.

Suggestions

Consolidate the 'Common Scenarios' section, which largely restates the Core Workflow steps; either trim it to trigger-routing guidance ('if user says X, start at phase Y') or move detailed approaches into a reference file.

Remove concept explanations Claude can infer, such as the 'What is an MDF' preamble, and keep only the ISO-13485-specific contents list and process.

Consider moving the 'Quick Reference' 31-procedures list and regulatory/regional summary into references/ so the SKILL.md body stays a lean overview pointing to detail files.

Dimension	Reasoning	Score
Conciseness	Mostly efficient and domain-specific, but the ~670-line body includes redundancy (the Common Scenarios section restates Core Workflow steps) and some concept explanation Claude can infer (e.g. 'What is an MDF'), so it could be tightened rather than earning the lean score-3 anchor.	2 / 3
Actionability	Provides executable guidance throughout — the concrete command 'python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json', specific template/reference file paths, explicit clause numbers, and placeholder-replacement instructions ([COMPANY NAME], [DATE]) make it copy-paste ready.	3 / 3
Workflow Clarity	Sequences the work into 5 numbered phases with explicit validation checkpoints — 'Validate completeness' checklists, the Quality Manual validation checklist, and the pre-audit 'Address findings → correct → verify effectiveness' feedback loop — matching the clear-sequence-with-validation anchor.	3 / 3
Progressive Disclosure	The body is an overview/navigation hub pointing one level deep to real bundle files (verified: references/.md, scripts/gap_analyzer.py, assets/templates/), each clearly signaled with a description in the Resources section, with detailed reference material appropriately split out of SKILL.md.	3 / 3
	Total	11 / 12 Passed

Description

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.

The description is specific, trigger-rich, and clearly answers both what the skill does and when to use it, with a distinct medical-device-regulatory niche. It uses appropriate third-person voice with no fluff or over-claims.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete actions: '(1) conducting gap analysis', '(2) creating Quality Manuals', '(3) developing required procedures and work instructions', '(4) preparing Medical Device Files', matching the score-3 anchor that lists several specific concrete actions.	3 / 3
Completeness	Explicitly answers both what ('Comprehensive toolkit for preparing ISO 13485 certification documentation') and when ('Use when users need help with ISO 13485 QMS documentation... Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR'), matching the anchor requiring explicit triggers for both.	3 / 3
Trigger Term Quality	Covers natural terms users would say — 'ISO 13485', 'medical device regulations', 'QMS certification', 'FDA QMSR', 'EU MDR', 'quality system documentation' — giving good coverage of common variations a user would naturally mention.	3 / 3
Distinctiveness Conflict Risk	ISO 13485 medical device QMS certification is a clear niche with distinct triggers (FDA QMSR, EU MDR, Medical Device Files) unlikely to overlap with or conflict against other skills.	3 / 3
	Total	12 / 12 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: 52845c3

Reviewed: about 13 hours ago

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