OpenClaw

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.

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技能说明

Risk Management Specialist

ISO 14971:2019 risk management implementation throughout the medical device lifecycle.

Risk Management Planning Workflow
Risk Analysis Workflow
Risk Evaluation Workflow
Risk Control Workflow
Post-Production Risk Management
Risk Assessment Templates
Decision Frameworks
Tools and References

Risk Management Planning Workflow

Establish risk management process per ISO 14971.

Workflow: Create Risk Management Plan

Define scope of risk management activities:
- Medical device identification
- Lifecycle stages covered
- Applicable standards and regulations
Establish risk acceptability criteria:
- Define probability categories (P1-P5)
- Define severity categories (S1-S5)
- Create risk matrix with acceptance thresholds
Assign responsibilities:
- Risk management lead
- Subject matter experts
- Approval authorities
Define verification activities:
- Methods for control verification
- Acceptance criteria
Plan production and post-production activities:
- Information sources
- Review triggers
- Update procedures
Obtain plan approval
Establish risk management file
Validation: Plan approved; acceptability criteria defined; responsibilities assigned; file established

Risk Management Plan Content

Section	Content	Evidence
Scope	Device and lifecycle coverage	Scope statement
Criteria	Risk acceptability matrix	Risk matrix document
Responsibilities	Roles and authorities	RACI chart
Verification	Methods and acceptance	Verification plan
Production/Post-Production	Monitoring activities	Surveillance plan

Risk Acceptabil...

来源信息

Source: github
Repository: openclaw/skills
Path: skills/alirezarezvani/risk-management-specialist
Version: —
Commit: 69cd6d95ad5695a4f8135b5cc537da86a1e4daa1
分类来源: rules
状态: active
可见性: public

这些信息来自收录时的来源分析，可能滞后；使用前请核对最新来源文件。

来源内容

SKILL.md

# Risk Management Specialist

ISO 14971:2019 risk management implementation throughout the medical device lifecycle.

---

## Table of Contents

- [Risk Management Planning Workflow](#risk-management-planning-workflow)
- [Risk Analysis Workflow](#risk-analysis-workflow)
- [Risk Evaluation Workflow](#risk-evaluation-workflow)
- [Risk Control Workflow](#risk-control-workflow)
- [Post-Production Risk Management](#post-production-risk-management)
- [Risk Assessment Templates](#risk-assessment-templates)
- [Decision Frameworks](#decision-frameworks)
- [Tools and References](#tools-and-references)

---

## Risk Management Planning Workflow

Establish risk management process per ISO 14971.

### Workflow: Create Risk Management Plan

1. Define scope of risk management activities:
   - Medical device identification
   - Lifecycle stages covered
   - Applicable standards and regulations
2. Establish risk acceptability criteria:
   - Define probability categories (P1-P5)
   - Define severity categories (S1-S5)
   - Create risk matrix with acceptance thresholds
3. Assign responsibilities:
   - Risk management lead
   - Subject matter experts
   - Approval authorities
4. Define verification activities:
   - Methods for control verification
   - Acceptance criteria
5. Plan production and post-production activities:
   - Information sources
   - Review triggers
   - Update procedures
6. Obtain plan approval
7. Establish risk management file
8. **Validation:** Plan approved; acceptability criteria defined; responsibilities assigned; file established

### Risk Management Plan Content

| Section | Content | Evidence |
|---------|---------|----------|
| Scope | Device and lifecycle coverage | Scope statement |
| Criteria | Risk acceptability matrix | Risk matrix document |
| Responsibilities | Roles and authorities | RACI chart |
| Verification | Methods and acceptance | Verification plan |
| Production/Post-Production | Monitoring activities | Surveillance plan |

### Risk Acceptabil...

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