Skill · em Documentar e entregar

risk-management-specialist

Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control…

Procedência

Origem: davila7/claude-code-templates
Caminho: cli-tool/components/skills/enterprise-communication/risk-management-specialist
Versão fixada: 57f899e5394bb8ca166f38eacae8f0853cbfe033
Licença: MIT
Espelhado em 25/09/2026
1 download no Claude Code Templates (lido em 25/09/2026)

Antes de instalar

4 arquivos · 12,4 KB · inclui 1 script que executa: scripts/example.py

Instalar na sua CLI

O comando baixa a versão fixada (commit 57f899e) direto da origem, para a pasta que a CLI lê. Precisa de curl (macOS e Linux); no Windows não há comando, porque o Rook Labs é para macOS.

Claude Code

Neste projeto: instala em .claude/skills/risk-management-specialist/.

d=".claude/skills/risk-management-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/risk-management-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.claude/skills/risk-management-specialist/.

d="$HOME/.claude/skills/risk-management-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/risk-management-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Codex

Neste projeto: instala em .agents/skills/risk-management-specialist/.

d=".agents/skills/risk-management-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/risk-management-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.agents/skills/risk-management-specialist/.

d="$HOME/.agents/skills/risk-management-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/risk-management-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Antigravity

Neste projeto: instala em .agents/skills/risk-management-specialist/.

d=".agents/skills/risk-management-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/risk-management-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.gemini/antigravity-cli/skills/risk-management-specialist/.

d="$HOME/.gemini/antigravity-cli/skills/risk-management-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/risk-management-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Peça ao Rook

Já usa o Rook Labs? Cole no chat do Rook: instale a skill https://rooklabs.sh/marketplace/cct.risk-management-specialist

Prévia do SKILL.md

---
name: risk-management-specialist
description: Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification,…
---

# Senior Risk Management Specialist

Expert-level medical device risk management implementing ISO 14971 throughout the complete product lifecycle with comprehensive risk analysis, evaluation, control, and post-production monitoring capabilities.

## Core Risk Management Competencies

### 1. Risk Management Process Implementation (ISO 14971)
Establish and maintain comprehensive risk management processes integrated throughout the product development and lifecycle.

**Risk Management Process Framework:**
```
ISO 14971 RISK MANAGEMENT PROCESS
├── Risk Management Planning
│   ├── Risk management plan development
│   ├── Risk acceptability criteria definition
│   ├── Risk management team formation
│   └── Risk management file establishment
├── Risk Analysis
│   ├── Intended use and reasonably foreseeable misuse
│   ├── Hazard identification and analysis
│   ├── Hazardous situation evaluation
│   └── Risk estimation and documentation
├── Risk Evaluation
│   ├── Risk acceptability assessment
│   ├── Risk benefit analysis
│   ├── Risk control necessity determination
│   └── Risk evaluation documentation
├── Risk Control
│   ├── Risk control option analysis
│   ├── Risk control measure implementation
│   ├── Residual risk evaluation
│   └── Risk control effectiveness verification
└── Production and Post-Production Information
    ├── Information collection and analysis
    ├── Risk management file updates
…

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