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.
Install via CLI (Recommended)
clawhub install openclaw/skills/skills/ayangai/risk-management-iso14971Risk Management Specialist
ISO 14971:2019 risk management implementation throughout the medical device lifecycle.
Table of Contents
- 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 Acceptability Matrix (5x5)
| Probability \ Severity | Negligible | Minor | Serious | Critical | Catastrophic |
|---|---|---|---|---|---|
| Frequent (P5) | Medium | High | High | Unacceptable | Unacceptable |
| Probable (P4) | Medium | Medium | High | High | Unacceptable |
| Occasional (P3) | Low | Medium | Medium | High | High |
| Remote (P2) | Low | Low | Medium | Medium | High |
| Improbable (P1) | Low | Low | Low | Medium | Medium |
Risk Level Actions
| Level | Acceptable | Action Required |
|---|---|---|
| Low | Yes | Document and accept |
| Medium | ALARP | Reduce if practicable; document rationale |
| High | ALARP | Reduction required; demonstrate ALARP |
| Unacceptable | No | Design change mandatory |
Risk Analysis Workflow
Identify hazards and estimate risks systematically.
Workflow: Conduct Risk Analysis
Metadata
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Find the right skillPaste this into your clawhub.json to enable this plugin.
{
"plugins": {
"official-ayangai-risk-management-iso14971": {
"enabled": true,
"auto_update": true
}
}
}