Skills risk-management-specialist

📦

risk-management-specialist

Name: risk-management-specialist
Author: davila7

Content revision r2 Safe ⚙️ External commands

Build Medical Device Risk Management Files

Medical device teams need consistent, traceable risk decisions across the product lifecycle. This skill structures ISO 14971 analysis, controls, verification, and post-production review.

Supports: Claude Codex Code(CC)

🥇 83 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/davila7-risk-management-specialist.md and its manifest at https://skillstore.io/api/skills/davila7-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/davila7-risk-management-specialist.md Signed manifest GET /api/skills/davila7-risk-management-specialist/manifest Signed lockfile GET /api/skills/davila7-risk-management-specialist/lockfile

Test it

Using "risk-management-specialist". Create a preliminary hazard analysis for a battery-powered infusion pump used in a hospital.

Expected outcome:

Hazard: unintended energy delivery. Hazardous situation: excessive infusion reaches the patient after a control failure.
Potential harm: overdose with serious clinical deterioration. Evidence needed: dose limits, alarm performance, fault testing, and clinical severity rationale.
Control direction: prevent unsafe delivery by design, add independent detection, verify shutdown behavior, then evaluate residual risk.

Using "risk-management-specialist". Review a complaint trend showing intermittent loss of wireless monitoring.

Expected outcome:

Signal assessment: compare frequency, affected versions, use environments, and clinical consequences with existing risk estimates.
Risk file impact: reassess communication-loss sequences, alarm reliance, detection time, and foreseeable user response.
Next actions: investigate root cause, verify local safety behavior, evaluate labeling, and document the updated benefit-risk conclusion.

Using "risk-management-specialist". Define verification evidence for a software safety control.

Expected outcome:

Control objective: prevent an invalid sensor value from driving therapy.
Evidence set: requirements traceability, boundary tests, fault-injection results, independence review, and unresolved anomaly assessment.
Acceptance basis: predefined expected behavior and objective pass criteria linked to the hazardous situation.

Security Audit

Safe

v9 • 7/23/2026 Open versioned report

All 16 medium static findings are false positives. Four are Markdown fence delimiters, and twelve are inline-code resource names that do not execute commands. No prompt injection or other intent-level security issue was found.

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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https://skillstore.io/skills/davila7-risk-management-specialist/audits/9?utm_source=security_passport&utm_medium=share&utm_campaign=versioned_report

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Academic citations (APA · BibTeX · CFF)

APA citation

davila7. (2026). risk-management-specialist security audit report (audit version 9) [Author version unspecified]. Skillstore. https://skillstore.io/skills/davila7-risk-management-specialist/audits/9

BibTeX citation

@techreport{davila7-davila7-risk-management-specialist-2026,
  author = {davila7},
  title = {risk-management-specialist security audit report (audit version 9)},
  institution = {Skillstore},
  year = {2026},
  number = {9},
  url = {https://skillstore.io/skills/davila7-risk-management-specialist/audits/9},
  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 9)"
version: "unspecified"
type: report
authors:
  - name: "davila7"
date-released: "2026-07-23"
url: "https://skillstore.io/skills/davila7-risk-management-specialist/audits/9"
identifiers:
  - type: other
    value: "skillstore:davila7-risk-management-specialist:audit:9"
    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

alirezarezvani-risk-management-specialist

Skillstore Score 84

Evidence Confidence High

Skillstore usage 16

Updated

2026-08-21

davila7 Current

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

Plan Product Risk Activities

Create a lifecycle risk management plan with responsibilities, review points, acceptability criteria, and required records.

Analyze Software Hazards

Connect software failure modes, hazardous situations, controls, and verification evidence within an IEC 62304 development process.

Review Post-Market Signals

Assess complaints, vigilance reports, and clinical findings for changes to risk estimates, controls, and benefit-risk conclusions.

Try These Prompts

Outline a Risk Management Plan

Create an ISO 14971 risk management plan outline for [device]. Include scope, responsibilities, review milestones, acceptability criteria, required records, and post-production activities.

Build a Preliminary Hazard Analysis

Develop a preliminary hazard analysis for [device and intended use]. Cover energy, biological, software, cybersecurity, usability, and environmental hazards. State assumptions and missing evidence.

Evaluate Risk Controls

Review these hazards, risk estimates, and proposed controls: [details]. Apply the ISO 14971 control hierarchy, identify verification evidence, and flag unsupported residual-risk conclusions.

Perform a Lifecycle Risk File Review

Assess this risk file and post-production evidence: [details]. Trace new signals to hazards, reassess risk and benefit-risk conclusions, and propose prioritized updates with accountable owners.

Best Practices

Provide intended use, users, environments, device architecture, and available evidence before requesting risk analysis.
Supply approved severity, probability, and acceptability criteria so evaluations follow organizational policy.
Require traceability from hazards through controls, verification evidence, residual risk, and post-production review.

Avoid

Do not treat generated risk records as approved evidence without cross-functional review and document control.
Do not assign numerical probabilities when supporting data and estimation methods are unavailable.
Do not rely on warnings or training before considering inherent safety and protective measures.

Frequently Asked Questions

Does this skill certify ISO 14971 compliance?

No. It structures analysis and documentation, but qualified personnel must confirm standards, evidence, approvals, and regulatory suitability.

Can it create a complete risk management file?

It can draft the structure and content from supplied evidence. Final records require product-specific data, traceability, review, and controlled approval.

Does it support software medical devices?

Yes. It addresses software hazards and IEC 62304 integration, including safety classification, controls, verification, and anomaly considerations.

Can it assess cybersecurity risks?

Yes. It can organize assets, threats, vulnerabilities, patient-safety impacts, controls, monitoring, and residual-risk questions from supplied information.

What information produces the best analysis?

Provide intended use, architecture, users, environments, hazards, complaint data, control evidence, and approved risk acceptability criteria.

Are the listed automation scripts and templates included?

No. The package contains placeholder support files, while several resources named in the skill instructions are not included.