Risk 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

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

Risk Acceptability Matrix (5x5)

Risk Level Actions

EU MDR — AFAP, not ALARP: For CE-marked devices, risks must be reduced as far as possible (AFAP) without economic considerations (MDR Annex I, GSPR 1–4; EN ISO 14971:2019/A11:2021 Z-annexes deviation). ALARP ("as low as reasonably practicable"), which permits cost-benefit weighing in acceptability decisions, is not an acceptable criterion under the EU MDR — a notified body will flag it. ISO 14971:2019 itself removed ALARP from the normative text. ALARP may persist in some non-EU jurisdictions (e.g., the UK HSE tradition); if used outside the EU, flag the deviation from EU requirements explicitly.

Risk Analysis Workflow

Identify hazards and estimate risks systematically.

Workflow: Conduct Risk Analysis

1. Define intended use and reasonably foreseeable misuse:
   • Medical indication
   • Patient population
   • User population
   • Use environment
2. Select analysis method(s):
   • FMEA for component/function analysis
   • FTA for system-level analysis
   • HAZOP for process deviations
   • Use Error Analysis for user interaction
3. Identify hazards by category:
   • Energy hazards (electrical, mechanical, thermal)
   • Biological hazards (bioburden, biocompatibility)
   • Chemical hazards (residues, leachables)
   • Operational hazards (software, use errors)
4. Determine hazardous situations:
   • Sequence of events
   • Foreseeable misuse scenarios
   • Single fault conditions
5. Estimate probability of harm (P1-P5)
6. Estimate severity of harm (S1-S5)
7. Document in hazard analysis worksheet
8. Validation: All hazard categories addressed; all hazards documented; probability and severity assigned

Hazard Categories Checklist

Analysis Method Selection

Probability Criteria

Severity Criteria

See: references/risk-analysis-methods.md

Risk Evaluation Workflow

Evaluate risks against acceptability criteria.

Workflow: Evaluate Identified Risks

1. Calculate initial risk level from probability × severity
2. Compare to risk acceptability criteria
3. For each risk, determine:
   • Acceptable: Document and accept (EU MDR: still reduce as far as possible)
   • Reduction required (AFAP): Proceed to risk control
   • Unacceptable: Mandatory risk control
4. Document evaluation rationale
5. Identify risks requiring benefit-risk analysis
6. Complete benefit-risk analysis if applicable
7. Compile risk evaluation summary
8. Validation: All risks evaluated; acceptability determined; rationale documented

Risk Evaluation Decision Tree

Risk Estimated
      │
      ▼
Apply Acceptability Criteria
      │
      ├── Low Risk ──────────► Accept and document
      │
      ├── Medium Risk ───────► Reduce as far as possible (AFAP)
      │   │                    Document why further reduction impossible
      │   ▼
      │   Further reduction possible?
      │   │
      │   Yes──► Implement control
      │   No───► Document AFAP rationale (no economic considerations)
      │
      ├── High Risk ─────────► Risk reduction required
      │   │                    Must demonstrate reduction AFAP
      │   ▼
      │   Implement control
      │   Verify residual risk
      │
      └── Unacceptable ──────► Design change mandatory
                               Cannot proceed without control

AFAP Demonstration Requirements (EU MDR)

Economic considerations (cost of further risk reduction) must not enter the EU acceptability decision (MDR Annex I GSPR 2; EN ISO 14971:2019/A11:2021). Cost may inform business decisions about whether to market the device — never whether a risk is acceptable.

Benefit-Risk Analysis Triggers

Risk Control Workflow

Implement and verify risk control measures.

Workflow: Implement Risk Controls

1. Identify risk control options:
   • Inherent safety by design (Priority 1)
   • Protective measures in device (Priority 2)
   • Information for safety (Priority 3)
2. Select optimal control following hierarchy
3. Analyze control for new hazards introduced
4. Document control in design requirements
5. Implement control in design
6. Develop verification protocol
7. Execute verification and document results
8. Evaluate residual risk with control in place
9. Validation: Control implemented; verification passed; residual risk acceptable; no unaddressed new hazards

Risk Control Hierarchy

Risk Control Option Analysis Template

RISK CONTROL OPTION ANALYSIS

Hazard ID: H-[XXX]
Hazard: [Description]
Initial Risk: P[X] × S[X] = [Level]

OPTIONS CONSIDERED:
| Option | Control Type | New Hazards | Feasibility | Selected |
|--------|--------------|-------------|-------------|----------|
| 1 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] |
| 2 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] |

SELECTED CONTROL: Option [X]
Rationale: [Justification for selection]

IMPLEMENTATION:
- Requirement: [REQ-XXX]
- Design Document: [Reference]

VERIFICATION:
- Method: [Test/Analysis/Review]
- Protocol: [Reference]
- Acceptance Criteria: [Criteria]

Risk Control Verification Methods

Residual Risk Evaluation

Post-Production Risk Management

Monitor and update risk management throughout product lifecycle.

Workflow: Post-Production Risk Monitoring

1. Identify information sources:
   • Customer complaints
   • Service reports
   • Vigilance/adverse events
   • Literature monitoring
   • Clinical studies
2. Establish collection procedures
3. Define review triggers:
   • New hazard identified
   • Increased frequency of known hazard
   • Serious incident
   • Regulatory feedback
4. Analyze incoming information for risk relevance
5. Update risk management file as needed
6. Communicate significant findings
7. Conduct periodic risk management review
8. Validation: Information sources monitored; file current; reviews completed per schedule

Information Sources

Risk Management File Update Triggers

Periodic Review Requirements

Risk Assessment Templates

→ See references/risk-assessment-templates.md for details

Decision Frameworks

Risk Control Selection

What is the risk level?
        │
        ├── Unacceptable ──► Can hazard be eliminated?
        │                    │
        │                Yes─┴─No
        │                 │     │
        │                 ▼     ▼
        │            Eliminate  Can protective
        │            hazard     measure reduce?
        │                           │
        │                       Yes─┴─No
        │                        │     │
        │                        ▼     ▼
        │                   Add       Add warning
        │                   protection + training
        │
        └── High/Medium ──► Apply hierarchy
                            starting at Level 1

New Hazard Analysis

Risk Acceptability Decision

Tools and References

Scripts

Risk Matrix Calculator Features:

• ISO 14971 5x5 risk matrix calculation
• FMEA RPN (Risk Priority Number) calculation
• Interactive mode for guided assessment
• Display risk criteria definitions
• JSON output for integration

References

Quick Reference: ISO 14971 Process

Related Skills