ISO 14971:2019 Implementation Guide

Complete implementation framework for medical device risk management per ISO 14971:2019.

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ISO 14971:2019 Implementation Guide

Complete implementation framework for medical device risk management per ISO 14971:2019.

Table of Contents

Risk Management Planning
Risk Analysis
Risk Evaluation
Risk Control
Overall Residual Risk Evaluation
Risk Management Report
Production and Post-Production Activities

Risk Management Planning

Risk Management Plan Content

Element	Requirement	Documentation
Scope	Medical device and lifecycle stages covered	Scope statement
Responsibilities	Personnel and authority assignments	Organization chart, RACI
Review Requirements	Timing and triggers for reviews	Review schedule
Acceptability Criteria	Risk acceptance matrix and policy	Risk acceptability criteria
Verification Activities	Methods for control verification	Verification plan
Production/Post-Production	Activities for ongoing risk management	Surveillance plan

Risk Management Plan Template

RISK MANAGEMENT PLAN

Document Number: RMP-[Product]-[Rev]
Product: [Device Name]
Revision: [X.X]
Effective Date: [Date]

1. SCOPE AND PURPOSE
   1.1 Medical Device Description: [Description]
   1.2 Intended Use: [Statement]
   1.3 Lifecycle Stages Covered: [Design/Production/Post-Market]
   1.4 Plan Objectives: [Objectives]

2. RESPONSIBILITIES AND AUTHORITIES
   | Role | Responsibility | Authority |
   |------|----------------|-----------|
   | Risk Management Lead | Overall RM process | RM decisions |
   | Design Engineer | Risk identification | Design changes |
   | QA Manager | RM file review | File approval |
   | Clinical | Clinical input | Clinical risk assessment |

3. RISK ACCEPTABILITY CRITERIA
   3.1 Risk Matrix: [Reference to matrix]
   3.2 Acceptability Policy: [Acceptable/ALARP/Unacceptable definitions]
   3.3 Benefit-Risk Considerations: [When applicable]

4. VERIFICATION ACTIVITIES
   4.1 Risk Control Verification Methods: [Test, Analysis, Review]
   4.2 Verification Timing: [Design phase, V&V]
   4.3 Acceptance Criteria: [Pass/fail criteria]

5. PRODUCTION AND POST-PRODUCTION
   5.1 Information Collection: [Sources]
   5.2 Review Triggers: [Events requiring review]
   5.3 Update Process: [RM file update procedure]

6. REVIEW AND APPROVAL
   Prepared By: _________________ Date: _______
   Reviewed By: _________________ Date: _______
   Approved By: _________________ Date: _______

Risk Acceptability Criteria Definition

Risk Level	Definition	Action Required
Broadly Acceptable	Risk so low that no action needed	Document and monitor
ALARP (Tolerable)	Risk reduced as low as reasonably practicable	Verify ALARP, consider benefit
Unacceptable	Risk exceeds acceptable threshold	Risk control mandatory

Risk Matrix Example (5x5)

Probability \ Severity	Negligible	Minor	Serious	Critical	Catastrophic
Frequent	Medium	High	High	Unacceptable	Unacceptable
Probable	Low	Medium	High	High	Unacceptable
Occasional	Low	Medium	Medium	High	High
Remote	Low	Low	Medium	Medium	High
Improbable	Low	Low	Low	Medium	Medium

Risk Level Actions:

Low (Acceptable): Document, no action required
Medium (ALARP): Consider risk reduction, document rationale
High (ALARP): Risk reduction required unless ALARP demonstrated
Unacceptable: Risk reduction mandatory before proceeding

Risk Analysis

Hazard Identification Methods

Method	Application	Standard Reference
FMEA	Component/subsystem failures	IEC 60812
FTA	System-level failure analysis	IEC 61025
HAZOP	Process hazard identification	IEC 61882
PHA	Preliminary hazard assessment	-
Use FMEA	Use-related hazards	IEC 62366-1

Intended Use Analysis Checklist

Category	Questions to Address
Medical Purpose	What condition is treated/diagnosed?
Patient Population	Age, health status, contraindications?
User Population	Healthcare professional, patient, caregiver?
Use Environment	Hospital, home, ambulatory?
Duration	Single use, repeated, continuous?
Body Contact	External, internal, implanted?

Hazard Categories (Informative Annex C)

Category	Examples
Energy	Electrical, thermal, mechanical, radiation
Biological	Bioburden, pyrogens, biocompatibility
Chemical	Residues, degradation products, leachables
Operational	Incorrect output, delayed function, unexpected operation
Information	Incomplete instructions, inadequate warnings
Use Environment	Electromagnetic, mechanical stress

Hazardous Situation Documentation

HAZARD ANALYSIS WORKSHEET

Product: [Device Name]
Analyst: [Name]
Date: [Date]

| ID | Hazard | Hazardous Situation | Sequence of Events | Harm | P1 | P2 | Initial Risk |
|----|--------|--------------------|--------------------|------|----|----|--------------|
| H-001 | [Hazard] | [Situation] | [Sequence] | [Harm] | [Prob] | [Sev] | [Level] |

P1 = Probability of hazardous situation occurring
P2 = Probability of harm given hazardous situation
Initial Risk = Risk before controls

Risk Estimation

Probability Categories:

Level	Term	Definition	Frequency
5	Frequent	Expected to occur	>10⁻³
4	Probable	Likely to occur	10⁻³ to 10⁻⁴
3	Occasional	May occur	10⁻⁴ to 10⁻⁵
2	Remote	Unlikely to occur	10⁻⁵ to 10⁻⁶
1	Improbable	Very unlikely	<10⁻⁶

Severity Categories:

Level	Term	Definition	Patient Impact
5	Catastrophic	Results in death	Death
4	Critical	Results in permanent impairment	Permanent impairment
3	Serious	Results in injury requiring intervention	Injury requiring treatment
2	Minor	Results in temporary injury	Temporary discomfort
1	Negligible	Inconvenience or temporary discomfort	No injury

Risk Evaluation

Evaluation Workflow

Apply risk acceptability criteria to estimated risk
Determine if risk is acceptable, ALARP, or unacceptable
For ALARP risks, document ALARP demonstration
For unacceptable risks, proceed to risk control
Document evaluation rationale
Validation: All risks evaluated against criteria; rationale documented

Risk Acceptability Decision

Initial Risk	Benefit Available	Decision
Acceptable	N/A	Accept, document
ALARP	No	Verify ALARP
ALARP	Yes	Include in benefit-risk
Unacceptable	No	Design change required
Unacceptable	Yes	Benefit-risk analysis

ALARP Demonstration

Criterion	Evidence Required
Technical feasibility	Analysis of alternatives
Economic proportionality	Cost-benefit assessment
State of the art	Review of similar devices
User acceptance	Stakeholder input

Risk Control

Risk Control Hierarchy

Priority	Control Type	Examples
1	Inherent safety by design	Remove hazard, substitute material
2	Protective measures in device	Guards, alarms, software limits
3	Information for safety	Warnings, training, IFU

Risk Control Option Analysis

RISK CONTROL OPTION ANALYSIS

Hazard ID: [H-XXX]
Risk Level: [Unacceptable/High]

| Option | Control Type | Effectiveness | Feasibility | New Risks | Selected |
|--------|--------------|---------------|-------------|-----------|----------|
| Option 1 | [Type] | [H/M/L] | [H/M/L] | [Yes/No] | [Yes/No] |
| Option 2 | [Type] | [H/M/L] | [H/M/L] | [Yes/No] | [Yes/No] |

Selected Option: [Option X]
Rationale: [Justification]

Risk Control Implementation Record

RISK CONTROL IMPLEMENTATION

Control ID: RC-[XXX]
Related Hazard: H-[XXX]

Control Description: [Description]
Control Type: [ ] Inherent Safety [ ] Protective Measure [ ] Information

Implementation:
- Specification/Requirement: [Reference]
- Design Document: [Reference]
- Verification Method: [Test/Analysis/Review]
- Verification Criteria: [Pass criteria]

Verification:
- Protocol Reference: [Document]
- Execution Date: [Date]
- Result: [ ] Pass [ ] Fail
- Evidence Reference: [Document]

New Risks Introduced: [ ] Yes [ ] No
If Yes: [New Hazard ID references]

Residual Risk:
- P1: [Probability]
- P2: [Severity]
- Residual Risk Level: [Level]

Approved By: _________________ Date: _______

Risk Control Verification Methods

Method	Application	Evidence
Test	Quantifiable control effectiveness	Test report
Inspection	Physical control presence	Inspection record
Analysis	Design analysis confirmation	Analysis report
Review	Document/drawing review	Review record

Overall Residual Risk Evaluation

Evaluation Process

Compile all individual residual risks
Consider cumulative effects of residual risks
Assess overall residual risk acceptability
Conduct benefit-risk analysis if required
Document overall evaluation conclusion
Validation: All residual risks compiled; overall evaluation complete

Benefit-Risk Analysis

Factor	Assessment
Clinical Benefit	Documented therapeutic benefit
State of the Art	Comparison to alternative treatments
Patient Expectation	Benefit patient would accept
Medical Opinion	Clinical expert input
Risk Quantification	Residual risk characterization

Benefit-Risk Documentation

BENEFIT-RISK ANALYSIS

Product: [Device Name]
Date: [Date]

BENEFITS:
1. Primary Clinical Benefit: [Description]
   - Evidence: [Reference]
   - Magnitude: [Quantification]

2. Secondary Benefits: [List]

RISKS:
1. Residual Risks Summary:
   | Risk Category | Count | Highest Level |
   |---------------|-------|---------------|
   | Acceptable | [N] | Low |
   | ALARP | [N] | Medium/High |

2. Cumulative Considerations: [Assessment]

COMPARISON:
- State of the Art: [How device compares]
- Alternative Treatments: [Risk comparison]
- Patient Acceptance: [Expected acceptance]

CONCLUSION:
[ ] Benefits outweigh risks - Acceptable
[ ] Benefits do not outweigh risks - Not Acceptable

Rationale: [Justification]

Approved By: _________________ Date: _______

Risk Management Report

Report Content Requirements

Section	Content
Results of Risk Analysis	Summary of hazards and risks identified
Risk Control Decisions	Controls selected and implemented
Overall Residual Risk	Evaluation and acceptability conclusion
Benefit-Risk Conclusion	If applicable
Review and Approval	Formal sign-off

Risk Management Report Template

RISK MANAGEMENT REPORT

Document Number: RMR-[Product]-[Rev]
Product: [Device Name]
Date: [Date]

1. EXECUTIVE SUMMARY
   - Total hazards identified: [N]
   - Risk controls implemented: [N]
   - Residual risks: [N] acceptable, [N] ALARP
   - Overall conclusion: [Acceptable/Not Acceptable]

2. RISK ANALYSIS SUMMARY
   - Methods used: [FMEA, FTA, etc.]
   - Scope coverage: [Lifecycle stages]
   - Hazard categories addressed: [List]

3. RISK EVALUATION SUMMARY
   | Risk Level | Before Control | After Control |
   |------------|----------------|---------------|
   | Unacceptable | [N] | [N] |
   | High | [N] | [N] |
   | Medium | [N] | [N] |
   | Low | [N] | [N] |

4. RISK CONTROL SUMMARY
   - Inherent safety controls: [N]
   - Protective measures: [N]
   - Information for safety: [N]
   - All controls verified: [Yes/No]

5. OVERALL RESIDUAL RISK
   - Individual residual risks: [Summary]
   - Cumulative assessment: [Conclusion]
   - Acceptability: [Acceptable/ALARP demonstrated]

6. BENEFIT-RISK ANALYSIS (if applicable)
   - Conclusion: [Statement]

7. PRODUCTION AND POST-PRODUCTION
   - Monitoring plan: [Reference]
   - Review triggers: [List]

8. CONCLUSION
   [Statement of overall risk acceptability]

9. APPROVAL
   Risk Management Lead: _________________ Date: _______
   Quality Assurance: _________________ Date: _______
   Management Representative: _________________ Date: _______

Production and Post-Production Activities

Information Sources

Source	Information Type	Review Frequency
Complaints	Use-related issues, failures	Continuous
Service Reports	Field failures, repairs	Monthly
Vigilance Reports	Serious incidents	Immediate
Literature	Similar device issues	Quarterly
Regulatory Feedback	Authority communications	As received
Clinical Data	Post-market clinical follow-up	Per PMCF plan

Risk Management File Update Triggers

Trigger	Action Required
New hazard identified	Risk analysis update
Control failure	Risk control reassessment
Serious incident	Immediate risk review
Design change	Impact assessment
Standards update	Compliance review
Regulatory feedback	Risk evaluation update

Risk Management Review Record

RISK MANAGEMENT REVIEW RECORD

Review Date: [Date]
Review Type: [ ] Periodic [ ] Triggered
Trigger (if applicable): [Description]

INFORMATION REVIEWED:
| Source | Period | Findings |
|--------|--------|----------|
| Complaints | [Period] | [Summary] |
| Vigilance | [Period] | [Summary] |
| Literature | [Period] | [Summary] |

RISK MANAGEMENT FILE STATUS:
- Current and complete: [ ] Yes [ ] No
- Updates required: [ ] Yes [ ] No

ACTIONS:
| Action | Owner | Due Date |
|--------|-------|----------|
| [Action 1] | [Name] | [Date] |

CONCLUSION:
[ ] No changes to risk profile
[ ] Risk profile updated - see [Document Reference]
[ ] Further investigation required

Reviewed By: _________________ Date: _______

---name: iso-14971-2019-implementation-guidedescription: Complete implementation framework for medical device risk management per ISO 14971:2019.---# ISO 14971:2019 Implementation GuideComplete implementation framework for medical device risk management per ISO 14971:2019.---## Table of Contents- [Risk Management Planning](#risk-management-planning)- [Risk Analysis](#risk-analysis)- [Risk Evaluation](#risk-evaluation)- [Risk Control](#risk-control)- [Overall Residual Risk Evaluation](#overall-residual-risk-evaluation)- [Risk Management Report](#risk-management-report)- [Production and Post-Production Activities](#production-and-post-production-activities)---## Risk Management Planning### Risk Management Plan Content| Element | Requirement | Documentation ||---------|-------------|---------------|| Scope | Medical device and lifecycle stages covered | Scope statement || Responsibilities | Personnel and authority assignments | Organization chart, RACI || Review Requirements | Timing and triggers for reviews | Review schedule || Acceptability Criteria | Risk acceptance matrix and policy | Risk acceptability criteria || Verification Activities | Methods for control verification | Verification plan || Production/Post-Production | Activities for ongoing risk management | Surveillance plan |### Risk Management Plan Template```RISK MANAGEMENT PLANDocument Number: RMP-[Product]-[Rev]Product: [Device Name]Revision: [X.X]Effective Date: [Date]1. SCOPE AND PURPOSE 1.1 Medical Device Description: [Description] 1.2 Intended Use: [Statement] 1.3 Lifecycle Stages Covered: [Design/Production/Post-Market] 1.4 Plan Objectives: [Objectives]2. RESPONSIBILITIES AND AUTHORITIES | Role | Responsibility | Authority | |------|----------------|-----------| | Risk Management Lead | Overall RM process | RM decisions | | Design Engineer | Risk identification | Design changes | | QA Manager | RM file review | File approval | | Clinical | Clinical input | Clinical risk assessment |3. RISK ACCEPTABILITY CRITERIA 3.1 Risk Matrix: [Reference to matrix] 3.2 Acceptability Policy: [Acceptable/ALARP/Unacceptable definitions] 3.3 Benefit-Risk Considerations: [When applicable]4. VERIFICATION ACTIVITIES 4.1 Risk Control Verification Methods: [Test, Analysis, Review] 4.2 Verification Timing: [Design phase, V&V] 4.3 Acceptance Criteria: [Pass/fail criteria]5. PRODUCTION AND POST-PRODUCTION 5.1 Information Collection: [Sources] 5.2 Review Triggers: [Events requiring review] 5.3 Update Process: [RM file update procedure]6. REVIEW AND APPROVAL Prepared By: _________________ Date: _______ Reviewed By: _________________ Date: _______ Approved By: _________________ Date: _______```### Risk Acceptability Criteria Definition| Risk Level | Definition | Action Required ||------------|------------|-----------------|| Broadly Acceptable | Risk so low that no action needed | Document and monitor || ALARP (Tolerable) | Risk reduced as low as reasonably practicable | Verify ALARP, consider benefit || Unacceptable | Risk exceeds acceptable threshold | Risk control mandatory |### Risk Matrix Example (5x5)| Probability \ Severity | Negligible | Minor | Serious | Critical | Catastrophic ||------------------------|------------|-------|---------|----------|--------------|| Frequent | Medium | High | High | Unacceptable | Unacceptable || Probable | Low | Medium | High | High | Unacceptable || Occasional | Low | Medium | Medium | High | High || Remote | Low | Low | Medium | Medium | High || Improbable | Low | Low | Low | Medium | Medium |**Risk Level Actions:**- **Low (Acceptable):** Document, no action required- **Medium (ALARP):** Consider risk reduction, document rationale- **High (ALARP):** Risk reduction required unless ALARP demonstrated- **Unacceptable:** Risk reduction mandatory before proceeding---## Risk Analysis### Hazard Identification Methods| Method | Application | Standard Reference ||--------|-------------|-------------------|| FMEA | Component/subsystem failures | IEC 60812 || FTA | System-level failure analysis | IEC 61025 || HAZOP | Process hazard identification | IEC 61882 || PHA | Preliminary hazard assessment | - || Use FMEA | Use-related hazards | IEC 62366-1 |### Intended Use Analysis Checklist| Category | Questions to Address ||----------|---------------------|| Medical Purpose | What condition is treated/diagnosed? || Patient Population | Age, health status, contraindications? || User Population | Healthcare professional, patient, caregiver? || Use Environment | Hospital, home, ambulatory? || Duration | Single use, repeated, continuous? || Body Contact | External, internal, implanted? |### Hazard Categories (Informative Annex C)| Category | Examples ||----------|----------|| Energy | Electrical, thermal, mechanical, radiation || Biological | Bioburden, pyrogens, biocompatibility || Chemical | Residues, degradation products, leachables || Operational | Incorrect output, delayed function, unexpected operation || Information | Incomplete instructions, inadequate warnings || Use Environment | Electromagnetic, mechanical stress |### Hazardous Situation Documentation```HAZARD ANALYSIS WORKSHEETProduct: [Device Name]Analyst: [Name]Date: [Date]| ID | Hazard | Hazardous Situation | Sequence of Events | Harm | P1 | P2 | Initial Risk ||----|--------|--------------------|--------------------|------|----|----|--------------|| H-001 | [Hazard] | [Situation] | [Sequence] | [Harm] | [Prob] | [Sev] | [Level] |P1 = Probability of hazardous situation occurringP2 = Probability of harm given hazardous situationInitial Risk = Risk before controls```### Risk Estimation**Probability Categories:**| Level | Term | Definition | Frequency ||-------|------|------------|-----------|| 5 | Frequent | Expected to occur | >10⁻³ || 4 | Probable | Likely to occur | 10⁻³ to 10⁻⁴ || 3 | Occasional | May occur | 10⁻⁴ to 10⁻⁵ || 2 | Remote | Unlikely to occur | 10⁻⁵ to 10⁻⁶ || 1 | Improbable | Very unlikely | <10⁻⁶ |**Severity Categories:**| Level | Term | Definition | Patient Impact ||-------|------|------------|----------------|| 5 | Catastrophic | Results in death | Death || 4 | Critical | Results in permanent impairment | Permanent impairment || 3 | Serious | Results in injury requiring intervention | Injury requiring treatment || 2 | Minor | Results in temporary injury | Temporary discomfort || 1 | Negligible | Inconvenience or temporary discomfort | No injury |---## Risk Evaluation### Evaluation Workflow1. Apply risk acceptability criteria to estimated risk2. Determine if risk is acceptable, ALARP, or unacceptable3. For ALARP risks, document ALARP demonstration4. For unacceptable risks, proceed to risk control5. Document evaluation rationale6. **Validation:** All risks evaluated against criteria; rationale documented### Risk Acceptability Decision| Initial Risk | Benefit Available | Decision ||--------------|-------------------|----------|| Acceptable | N/A | Accept, document || ALARP | No | Verify ALARP || ALARP | Yes | Include in benefit-risk || Unacceptable | No | Design change required || Unacceptable | Yes | Benefit-risk analysis |### ALARP Demonstration| Criterion | Evidence Required ||-----------|-------------------|| Technical feasibility | Analysis of alternatives || Economic proportionality | Cost-benefit assessment || State of the art | Review of similar devices || User acceptance | Stakeholder input |---## Risk Control### Risk Control Hierarchy| Priority | Control Type | Examples ||----------|--------------|----------|| 1 | Inherent safety by design | Remove hazard, substitute material || 2 | Protective measures in device | Guards, alarms, software limits || 3 | Information for safety | Warnings, training, IFU |### Risk Control Option Analysis```RISK CONTROL OPTION ANALYSISHazard ID: [H-XXX]Risk Level: [Unacceptable/High]| Option | Control Type | Effectiveness | Feasibility | New Risks | Selected ||--------|--------------|---------------|-------------|-----------|----------|| Option 1 | [Type] | [H/M/L] | [H/M/L] | [Yes/No] | [Yes/No] || Option 2 | [Type] | [H/M/L] | [H/M/L] | [Yes/No] | [Yes/No] |Selected Option: [Option X]Rationale: [Justification]```### Risk Control Implementation Record```RISK CONTROL IMPLEMENTATIONControl ID: RC-[XXX]Related Hazard: H-[XXX]Control Description: [Description]Control Type: [ ] Inherent Safety [ ] Protective Measure [ ] InformationImplementation:- Specification/Requirement: [Reference]- Design Document: [Reference]- Verification Method: [Test/Analysis/Review]- Verification Criteria: [Pass criteria]Verification:- Protocol Reference: [Document]- Execution Date: [Date]- Result: [ ] Pass [ ] Fail- Evidence Reference: [Document]New Risks Introduced: [ ] Yes [ ] NoIf Yes: [New Hazard ID references]Residual Risk:- P1: [Probability]- P2: [Severity]- Residual Risk Level: [Level]Approved By: _________________ Date: _______```### Risk Control Verification Methods| Method | Application | Evidence ||--------|-------------|----------|| Test | Quantifiable control effectiveness | Test report || Inspection | Physical control presence | Inspection record || Analysis | Design analysis confirmation | Analysis report || Review | Document/drawing review | Review record |---## Overall Residual Risk Evaluation### Evaluation Process1. Compile all individual residual risks2. Consider cumulative effects of residual risks3. Assess overall residual risk acceptability4. Conduct benefit-risk analysis if required5. Document overall evaluation conclusion6. **Validation:** All residual risks compiled; overall evaluation complete### Benefit-Risk Analysis| Factor | Assessment ||--------|------------|| Clinical Benefit | Documented therapeutic benefit || State of the Art | Comparison to alternative treatments || Patient Expectation | Benefit patient would accept || Medical Opinion | Clinical expert input || Risk Quantification | Residual risk characterization |### Benefit-Risk Documentation```BENEFIT-RISK ANALYSISProduct: [Device Name]Date: [Date]BENEFITS:1. Primary Clinical Benefit: [Description] - Evidence: [Reference] - Magnitude: [Quantification]2. Secondary Benefits: [List]RISKS:1. Residual Risks Summary: | Risk Category | Count | Highest Level | |---------------|-------|---------------| | Acceptable | [N] | Low | | ALARP | [N] | Medium/High |2. Cumulative Considerations: [Assessment]COMPARISON:- State of the Art: [How device compares]- Alternative Treatments: [Risk comparison]- Patient Acceptance: [Expected acceptance]CONCLUSION:[ ] Benefits outweigh risks - Acceptable[ ] Benefits do not outweigh risks - Not AcceptableRationale: [Justification]Approved By: _________________ Date: _______```---## Risk Management Report### Report Content Requirements| Section | Content ||---------|---------|| Results of Risk Analysis | Summary of hazards and risks identified || Risk Control Decisions | Controls selected and implemented || Overall Residual Risk | Evaluation and acceptability conclusion || Benefit-Risk Conclusion | If applicable || Review and Approval | Formal sign-off |### Risk Management Report Template```RISK MANAGEMENT REPORTDocument Number: RMR-[Product]-[Rev]Product: [Device Name]Date: [Date]1. EXECUTIVE SUMMARY - Total hazards identified: [N] - Risk controls implemented: [N] - Residual risks: [N] acceptable, [N] ALARP - Overall conclusion: [Acceptable/Not Acceptable]2. RISK ANALYSIS SUMMARY - Methods used: [FMEA, FTA, etc.] - Scope coverage: [Lifecycle stages] - Hazard categories addressed: [List]3. RISK EVALUATION SUMMARY | Risk Level | Before Control | After Control | |------------|----------------|---------------| | Unacceptable | [N] | [N] | | High | [N] | [N] | | Medium | [N] | [N] | | Low | [N] | [N] |4. RISK CONTROL SUMMARY - Inherent safety controls: [N] - Protective measures: [N] - Information for safety: [N] - All controls verified: [Yes/No]5. OVERALL RESIDUAL RISK - Individual residual risks: [Summary] - Cumulative assessment: [Conclusion] - Acceptability: [Acceptable/ALARP demonstrated]6. BENEFIT-RISK ANALYSIS (if applicable) - Conclusion: [Statement]7. PRODUCTION AND POST-PRODUCTION - Monitoring plan: [Reference] - Review triggers: [List]8. CONCLUSION [Statement of overall risk acceptability]9. APPROVAL Risk Management Lead: _________________ Date: _______ Quality Assurance: _________________ Date: _______ Management Representative: _________________ Date: _______```---## Production and Post-Production Activities### Information Sources| Source | Information Type | Review Frequency ||--------|------------------|------------------|| Complaints | Use-related issues, failures | Continuous || Service Reports | Field failures, repairs | Monthly || Vigilance Reports | Serious incidents | Immediate || Literature | Similar device issues | Quarterly || Regulatory Feedback | Authority communications | As received || Clinical Data | Post-market clinical follow-up | Per PMCF plan |### Risk Management File Update Triggers| Trigger | Action Required ||---------|-----------------|| New hazard identified | Risk analysis update || Control failure | Risk control reassessment || Serious incident | Immediate risk review || Design change | Impact assessment || Standards update | Compliance review || Regulatory feedback | Risk evaluation update |### Risk Management Review Record```RISK MANAGEMENT REVIEW RECORDReview Date: [Date]Review Type: [ ] Periodic [ ] TriggeredTrigger (if applicable): [Description]INFORMATION REVIEWED:| Source | Period | Findings ||--------|--------|----------|| Complaints | [Period] | [Summary] || Vigilance | [Period] | [Summary] || Literature | [Period] | [Summary] |RISK MANAGEMENT FILE STATUS:- Current and complete: [ ] Yes [ ] No- Updates required: [ ] Yes [ ] NoACTIONS:| Action | Owner | Due Date ||--------|-------|----------|| [Action 1] | [Name] | [Date] |CONCLUSION:[ ] No changes to risk profile[ ] Risk profile updated - see [Document Reference][ ] Further investigation requiredReviewed By: _________________ Date: _______```

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