Skills risk-management-specialist

📦

risk-management-specialist

Name: risk-management-specialist
Author: alirezarezvani

Content revision r1 Safe ⚙️ External commands

Manage Medical Device Risk Files

Medical device teams need consistent risk management evidence across design, regulatory, and post-market work. This skill guides ISO 14971 planning, analysis, controls, and file maintenance.

Supports: Claude Codex Code(CC)

🥇 84 Gold

Install with my Agent

Copy this request to your Agent. It includes the canonical Skill page and manifest.

Agent request

Review the Skillstore skill "risk-management-specialist" from https://skillstore.io/skills/alirezarezvani-risk-management-specialist.md and its manifest at https://skillstore.io/api/skills/alirezarezvani-risk-management-specialist/manifest. Verify the artifact. You may proceed after verification, subject to the environment's own policy.

Your Agent should still show its plan and request any confirmation required by the security policy.

Agent-readable resources

Use these links when an AI agent, crawler, or script needs clean context instead of reading the full page.

Markdown detail GET /skills/alirezarezvani-risk-management-specialist.md Signed manifest GET /api/skills/alirezarezvani-risk-management-specialist/manifest Signed lockfile GET /api/skills/alirezarezvani-risk-management-specialist/lockfile

Test it

Using "risk-management-specialist". A wearable monitor is entering design verification, and the team needs a risk management file review.

Expected outcome:

The skill produces a review plan covering intended use, hazards, hazardous situations, controls, verification records, residual risks, and missing traceability.

Using "risk-management-specialist". A complaint trend suggests intermittent alarm delays in a connected infusion device.

Expected outcome:

The skill links the signal to cybersecurity, software, use-error, and clinical risk questions, then recommends risk file and CAPA review actions.

Using "risk-management-specialist". A team has risk controls but no clear verification strategy.

Expected outcome:

The skill separates design controls, protective measures, and information for safety, then proposes verification evidence for each control type.

Security Audit

Safe

v6 • 7/6/2026 Open versioned report

All 16 static findings are false positives caused by markdown code fences or inline backticks in SKILL.md. I found no evidence of shell execution, command injection, prompt injection, or data exfiltration intent in the scanned files.

Files scanned

306

Lines analyzed

Review items

False positives ignored

Risk Factors

⚙️ External commands (16)

SKILL.md:16-43 SKILL.md:43-77 SKILL.md:77-90 SKILL.md:90-209 SKILL.md:209-210 SKILL.md:210-211 SKILL.md:211-212 SKILL.md:212-215 SKILL.md:215-216 SKILL.md:216-217 SKILL.md:217-218 SKILL.md:218-219 SKILL.md:219-222 SKILL.md:222-223 SKILL.md:223-224 SKILL.md:224-225

No confirmed security findings were detected by the latest completed static and semantic audit. This does not prove the skill has no side effects.

Audited by: codex View Audit History →

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Open versioned report

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https://skillstore.io/skills/alirezarezvani-risk-management-specialist/audits/6?utm_source=security_passport&utm_medium=share&utm_campaign=versioned_report

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Academic citations (APA · BibTeX · CFF)

APA citation

alirezarezvani. (2026). risk-management-specialist security audit report (audit version 6) [Author version unspecified]. Skillstore. https://skillstore.io/skills/alirezarezvani-risk-management-specialist/audits/6

BibTeX citation

@techreport{alirezarezvani-alirezarezvani-risk-management-specialist-2026,
  author = {alirezarezvani},
  title = {risk-management-specialist security audit report (audit version 6)},
  institution = {Skillstore},
  year = {2026},
  number = {6},
  url = {https://skillstore.io/skills/alirezarezvani-risk-management-specialist/audits/6},
  note = {Author version unspecified}
}

CITATION.cff

cff-version: 1.2.0
message: "If you use this Skill, cite its author and this versioned security audit report."
title: "risk-management-specialist security audit report (audit version 6)"
version: "unspecified"
type: report
authors:
  - name: "alirezarezvani"
date-released: "2026-07-06"
url: "https://skillstore.io/skills/alirezarezvani-risk-management-specialist/audits/6"
identifiers:
  - type: other
    value: "skillstore:alirezarezvani-risk-management-specialist:audit:6"
    description: "Skillstore immutable audit report identifier"

Compare variants

2 installable variants

Each author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.

Why this variant is first

Highest Skillstore Score

Author / source Skillstore Score Evidence Confidence Skillstore usage Updated

alirezarezvani Recommended Current

alirezarezvani-risk-management-specialist

Skillstore Score 84

Evidence Confidence High

Skillstore usage 16

Updated

2026-08-21

davila7

davila7-risk-management-specialist

Skillstore Score 83

Evidence Confidence High

Skillstore usage 11

Updated

2026-08-21

Skillstore Score

Why this score Evidence Confidence: High

Architecture

Maintainability

Content

Community

Spec Compliance

What You Can Build

Create Risk Management Plans

Build an ISO 14971 plan with scope, responsibilities, criteria, lifecycle activities, and file structure.

Review Design Risk Evidence

Map hazards, foreseeable misuse, risk controls, and verification evidence during design control reviews.

Assess Post-Market Signals

Connect complaints, surveillance data, CAPA records, and clinical updates to risk file maintenance.

Try These Prompts

Start a Risk Plan

Create an ISO 14971 risk management plan outline for this medical device: [device type]. Include scope, responsibilities, criteria, lifecycle activities, and required records.

Identify Hazards

Review this intended use, user profile, and use environment: [details]. Identify likely hazards, hazardous situations, foreseeable misuse, and missing inputs.

Evaluate Risk Controls

Assess these proposed risk controls: [controls]. Check whether they follow the ISO 14971 control hierarchy and identify verification evidence needed for each control.

Update a Risk File

Analyze these post-market signals and design changes: [details]. Recommend risk file updates, benefit-risk review needs, and follow-up quality actions.

Best Practices

Provide the device intended use, users, environments, hazards, and current acceptability criteria.
Ask for traceable outputs that link hazards, controls, verification evidence, and residual risk decisions.
Use the output as a review aid and route final decisions through your quality system.

Avoid

Do not treat generated risk ratings as final without documented expert review.
Do not ask for generic hazards when product-specific use conditions are available.
Do not use the skill to bypass design control, CAPA, or regulatory review processes.