Name: risk-management-specialist
Rating: 73.6 (1 reviews)
Author: alirezarezvani

risk-management-specialist

Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.

Quality

91%

Does it follow best practices?

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Securityby

Passed

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The canonical home for this skill is risk-management-specialist in alirezarezvani/claude-skills

Quality

Content

88%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 well-structured, highly actionable regulatory skill body with explicit validation checkpoints throughout its workflows. Its main weakness is progressive disclosure: referenced bundle files are missing and some reference-grade material is inlined in SKILL.md.

Suggestions

Create the referenced files (references/risk-analysis-methods.md, references/risk-assessment-templates.md, references/iso14971-implementation-guide.md, scripts/risk_matrix_calculator.py) so the signaled links resolve, or remove the links.

Move the larger reference tables (e.g. full probability/severity criteria, information-source matrices) into the referenced files to slim SKILL.md toward a true overview.

Tighten or deduplicate criteria tables that restate the same P/S scales across sections to improve token efficiency.

Dimension	Reasoning	Score
Conciseness	The body is dense and mostly assumes Claude's competence (the AFAP-vs-ALARP callout is genuinely non-obvious), but at ~450 lines with some repeated criteria tables it could be trimmed slightly rather than scoring a clean 5.	4 / 5
Actionability	Provides concrete numbered workflows, copy-paste-ready templates (Risk Control Option Analysis), ASCII decision trees, and quantified P1-P5/S1-S5 criteria with frequencies — fully actionable guidance for an instruction skill.	5 / 5
Workflow Clarity	Every workflow ends with an explicit Validation: checkpoint (e.g. 'Plan approved; acceptability criteria defined; responsibilities assigned; file established') and the evaluation/control workflows include fix-and-retry feedback loops.	5 / 5
Progressive Disclosure	A table of contents plus well-signaled one-level-deep references (risk-analysis-methods.md, risk-assessment-templates.md, iso14971-implementation-guide.md, risk_matrix_calculator.py) give good navigation, but those referenced files do not exist in the bundle and some detail that could live in references is inlined.	4 / 5
	Total	18 / 20 Passed

Description

95%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 with a clear what/when structure and an unusually comprehensive trigger-term list. Only minor specificity gaps keep it from a perfect score across every dimension.

Dimension	Reasoning	Score
Specificity	Names the domain (medical device risk management, ISO 14971) and lists four concrete actions — 'risk analysis, risk evaluation, risk control, and post-production information analysis' — but leaves minor coverage gaps such as benefit-risk analysis as an action.	4 / 5
Completeness	It explicitly answers both what (specialist implementing ISO 14971 throughout the lifecycle, providing four named analyses) and when (concrete 'Use when user mentions...' trigger phrases).	5 / 5
Trigger Term Quality	The 'Use when user mentions...' clause covers a comprehensive set of natural terms and synonyms/acronyms — risk management, ISO 14971, FMEA, fault tree analysis, hazard identification, risk matrix, residual risk, risk acceptability, post-market risk.	5 / 5
Distinctiveness Conflict Risk	The medical-device / ISO 14971 niche is sharply defined with distinct triggers, making overlap with other skills minimal.	5 / 5
	Total	19 / 20 Passed

Validation

87%

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 — 14 / 16 Passed

Validation for skill structure

Criteria	Description	Result
relative_links	Relative link issues: 4 missing, 4 suspicious	Warning
referenced_paths_exist	Referenced path issues: 6 missing	Warning

	Total	14 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: .gemini/skills/risk-management-specialist/SKILL.md
Commit: 19392f7

Reviewed: ~4 hours ago

Table of Contents

Discovery Implementation Validation

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