risk-management-specialist

name	risk-management-specialist
description	Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
license	MIT + Commons Clause
metadata	{"version":"1.0.0","author":"borghei","category":"compliance","domain":"risk-management","updated":"2026-03-31T00:00:00.000Z","tags":["iso-14971","risk-analysis","fmea","risk-register","medical-device"]}

Risk Management Specialist

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

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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

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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 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

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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

Category	Examples	Analyzed
Electrical	Shock, burns, interference	☐
Mechanical	Crushing, cutting, entrapment	☐
Thermal	Burns, tissue damage	☐
Radiation	Ionizing, non-ionizing	☐
Biological	Infection, biocompatibility	☐
Chemical	Toxicity, irritation	☐
Software	Incorrect output, timing	☐
Use Error	Misuse, perception, cognition	☐
Environment	EMC, mechanical stress	☐

Analysis Method Selection

Situation	Recommended Method
Component failures	FMEA
System-level failure	FTA
Process deviations	HAZOP
User interaction	Use Error Analysis
Software behavior	Software FMEA
Early design phase	PHA

Probability Criteria

Level	Name	Description	Frequency
P5	Frequent	Expected to occur	>10⁻³
P4	Probable	Likely to occur	10⁻³ to 10⁻⁴
P3	Occasional	May occur	10⁻⁴ to 10⁻⁵
P2	Remote	Unlikely	10⁻⁵ to 10⁻⁶
P1	Improbable	Very unlikely	<10⁻⁶

Severity Criteria

Level	Name	Description	Harm
S5	Catastrophic	Death	Death
S4	Critical	Permanent impairment	Irreversible injury
S3	Serious	Injury requiring intervention	Reversible injury
S2	Minor	Temporary discomfort	No treatment needed
S1	Negligible	Inconvenience	No injury

See: references/risk-analysis-methods.md

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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
   • ALARP: 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 ───────► Consider risk reduction
      │   │                    Document ALARP if not reduced
      │   ▼
      │   Practicable to reduce?
      │   │
      │   Yes──► Implement control
      │   No───► Document ALARP rationale
      │
      ├── High Risk ─────────► Risk reduction required
      │   │                    Must demonstrate ALARP
      │   ▼
      │   Implement control
      │   Verify residual risk
      │
      └── Unacceptable ──────► Design change mandatory
                               Cannot proceed without control

ALARP Demonstration Requirements

Criterion	Evidence Required
Technical feasibility	Analysis of alternative controls
Proportionality	Cost-benefit of further reduction
State of the art	Comparison to similar devices
Stakeholder input	Clinical/user perspectives

Benefit-Risk Analysis Triggers

Situation	Benefit-Risk Required
Residual risk remains high	Yes
No feasible risk reduction	Yes
Novel device	Yes
Unacceptable risk with clinical benefit	Yes
All risks low	No

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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

Priority	Control Type	Examples	Effectiveness
1	Inherent Safety	Eliminate hazard, fail-safe design	Highest
2	Protective Measures	Guards, alarms, automatic shutdown	High
3	Information	Warnings, training, IFU	Lower

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

Method	When to Use	Evidence
Test	Quantifiable performance	Test report
Inspection	Physical presence	Inspection record
Analysis	Design calculation	Analysis report
Review	Documentation check	Review record

Residual Risk Evaluation

After Control	Action
Acceptable	Document, proceed
ALARP achieved	Document rationale, proceed
Still unacceptable	Additional control or design change
New hazard introduced	Analyze and control new hazard

---

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

Source	Information Type	Review Frequency
Complaints	Use issues, failures	Continuous
Service	Field failures, repairs	Monthly
Vigilance	Serious incidents	Immediate
Literature	Similar device issues	Quarterly
Regulatory	Authority feedback	As received
Clinical	PMCF data	Per plan

Risk Management File Update Triggers

Trigger	Response Time	Action
Serious incident	Immediate	Full risk review
New hazard identified	30 days	Risk analysis update
Trend increase	60 days	Trend analysis
Design change	Before implementation	Impact assessment
Standards update	Per transition period	Gap analysis

Periodic Review Requirements

Review Element	Frequency
Risk management file completeness	Annual
Risk control effectiveness	Annual
Post-market information analysis	Quarterly
Risk-benefit conclusions	Annual or on new data

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Risk Assessment Templates

Hazard Analysis Worksheet

HAZARD ANALYSIS WORKSHEET

Product: [Device Name]
Document: HA-[Product]-[Rev]
Analyst: [Name]
Date: [Date]

| ID | Hazard | Hazardous Situation | Harm | P | S | Initial Risk | Control | Residual P | Residual S | Final Risk |
|----|--------|---------------------|------|---|---|--------------|---------|------------|------------|------------|
| H-001 | [Hazard] | [Situation] | [Harm] | [1-5] | [1-5] | [Level] | [Control ref] | [1-5] | [1-5] | [Level] |

FMEA Worksheet

FMEA WORKSHEET

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

| ID | Item | Function | Failure Mode | Effect | S | Cause | O | Control | D | RPN | Action |
|----|------|----------|--------------|--------|---|-------|---|---------|---|-----|--------|
| FM-001 | [Item] | [Function] | [Mode] | [Effect] | [1-10] | [Cause] | [1-10] | [Detection] | [1-10] | [S×O×D] | [Action] |

RPN Action Thresholds:
>200: Critical - Immediate action
100-200: High - Action plan required
50-100: Medium - Consider action
<50: Low - Monitor

Risk Management Report Summary

RISK MANAGEMENT REPORT

Product: [Device Name]
Date: [Date]
Revision: [X.X]

SUMMARY:
- Total hazards identified: [N]
- Risk controls implemented: [N]
- Residual risks: [N] Low, [N] Medium, [N] High
- Overall conclusion: [Acceptable / Not Acceptable]

RISK DISTRIBUTION:
| Risk Level | Before Control | After Control |
|------------|----------------|---------------|
| Unacceptable | [N] | 0 |
| High | [N] | [N] |
| Medium | [N] | [N] |
| Low | [N] | [N] |

CONTROLS IMPLEMENTED:
- Inherent safety: [N]
- Protective measures: [N]
- Information for safety: [N]

OVERALL RESIDUAL RISK: [Acceptable / ALARP Demonstrated]
BENEFIT-RISK CONCLUSION: [If applicable]

APPROVAL:
Risk Management Lead: _____________ Date: _______
Quality Assurance: _____________ Date: _______

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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

Question	If Yes	If No
Does control introduce new hazard?	Analyze new hazard	Proceed
Is new risk higher than original?	Reject control option	Acceptable trade-off
Can new hazard be controlled?	Add control	Reject control option

Risk Acceptability Decision

Condition	Decision
All risks Low	Acceptable
Medium risks with ALARP	Acceptable
High risks with ALARP documented	Acceptable if benefits outweigh
Any Unacceptable residual	Not acceptable - redesign

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Tools and References

Scripts

Tool	Purpose	Usage
risk_matrix_calculator.py	Calculate risk levels and FMEA RPN	python risk_matrix_calculator.py --help

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

Document	Content
iso14971-implementation-guide.md	Complete ISO 14971:2019 implementation with templates
risk-analysis-methods.md	FMEA, FTA, HAZOP, Use Error Analysis methods

Quick Reference: ISO 14971 Process

Stage	Key Activities	Output
Planning	Define scope, criteria, responsibilities	Risk Management Plan
Analysis	Identify hazards, estimate risk	Hazard Analysis
Evaluation	Compare to criteria, ALARP assessment	Risk Evaluation
Control	Implement hierarchy, verify	Risk Control Records
Residual	Overall assessment, benefit-risk	Risk Management Report
Production	Monitor, review, update	Updated RM File

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Related Skills

Skill	Integration Point
quality-manager-qms-iso13485	QMS integration
capa-officer	Risk-based CAPA
regulatory-affairs-head	Regulatory submissions
quality-documentation-manager	Risk file management

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AI-Specific Risk Management (ISO 14971 + AI Risk Considerations)

AI/ML Medical Device Risk Categories

Traditional ISO 14971 hazard categories must be extended for AI/ML-based devices:

AI-Specific Hazard	Description	Severity Potential	Detection Difficulty
Model bias	Discriminatory outputs across patient subgroups	S3-S5 (misdiagnosis)	High — requires subgroup analysis
Data drift	Input data distribution shifts from training data	S2-S4 (degraded performance)	Medium — requires monitoring
Concept drift	Clinical ground truth changes over time	S3-S5 (outdated predictions)	High — requires clinical validation
Adversarial inputs	Intentionally crafted inputs to deceive model	S2-S5 (incorrect output)	High — requires adversarial testing
Hallucination/confabulation	Plausible but incorrect outputs	S3-S5 (false diagnosis)	Medium — requires output validation
Training data poisoning	Corrupted training data leads to systematic errors	S3-S5	Very High — requires data provenance
Automation complacency	Users over-trust AI outputs	S3-S5 (missed clinical findings)	Medium — requires human factors study

AI Risk Analysis Methodology

Step 1: AI System Characterization
        → Define intended use, user population, clinical context
        → Classify: locked algorithm vs. adaptive vs. continuously learning
        → Map to SaMD risk framework (IMDRF)

Step 2: AI-Specific Hazard Identification
        → Apply standard ISO 14971 hazard categories
        → ADD: data quality hazards, algorithmic hazards, integration hazards
        → Consider: training data representativeness, edge cases, failure modes

Step 3: AI Failure Mode Analysis
        → Extend FMEA with AI-specific failure modes:
           - False positive/negative beyond acceptable rates
           - Performance degradation over time
           - Out-of-distribution input handling
           - Feature importance shift
        → For each failure mode: determine harm pathway to patient

Step 4: AI-Specific Risk Controls
        → Confidence thresholds (reject uncertain predictions)
        → Human-in-the-loop for high-risk decisions
        → Input validation and out-of-distribution detection
        → Continuous performance monitoring with drift detection
        → Automated model retraining safeguards
        → Fail-safe modes when AI system is unavailable

Step 5: AI Risk Monitoring Plan
        → Define performance metrics and acceptable thresholds
        → Establish monitoring frequency (real-time, daily, weekly)
        → Define retraining triggers and validation requirements
        → Plan for model versioning and rollback procedures

AI Risk Acceptability Considerations

Risk Factor	Additional Consideration for AI
Probability	Include statistical confidence intervals for model performance
Severity	Consider both direct harm and harm from delayed correct treatment
Detectability	Factor in opacity of AI decision-making (explainability)
Benefit	Quantify clinical benefit vs. non-AI alternative
ALARP	State-of-the-art includes current AI best practices (GMLP)

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Cybersecurity Risk Integration (IEC 81001-5-1)

Health Software Cybersecurity Risk Management

IEC 81001-5-1:2021 establishes cybersecurity lifecycle requirements for health software. Integrate with ISO 14971:

ISO 14971 Stage	IEC 81001-5-1 Integration	Combined Output
Risk Management Plan	Include cybersecurity scope, threat modeling methodology	Combined RM + cybersecurity plan
Hazard identification	Add cybersecurity threat identification (STRIDE, attack trees)	Extended hazard analysis with cyber threats
Risk estimation	Estimate probability based on threat landscape and exploitability	Risk register with cyber-specific likelihood factors
Risk control	Implement security controls as risk mitigations	Controls traceable to both safety and security risks
Residual risk	Evaluate residual cybersecurity risk	Combined residual risk assessment
Post-production	Monitor threat landscape, CVE databases, incident reports	Integrated PMS + security monitoring

Cybersecurity Threat Categories for Medical Devices

Threat Category	Examples	ISO 14971 Harm Pathway
Unauthorized access	Credential theft, privilege escalation	Modification of device settings → patient harm
Data breach	PHI exfiltration, ransomware	Loss of data availability → delayed treatment
Denial of service	Network flooding, resource exhaustion	Device unavailable → delayed diagnosis/treatment
Malware	Ransomware, trojans, supply chain compromise	Device malfunction → incorrect output
Data integrity	Man-in-the-middle, data manipulation	Corrupted clinical data → incorrect treatment
Supply chain	Compromised dependencies, malicious updates	Backdoor access → any harm pathway

Cybersecurity FMEA Extension

Add these columns to standard FMEA for cybersecurity failure modes:

CYBERSECURITY FMEA EXTENSION

| ID | Component | Security Function | Threat | Attack Vector | Exploitability | Impact | S | O | D | RPN | Security Control |
|----|-----------|-------------------|--------|---------------|---------------|--------|---|---|---|-----|-----------------|
| CS-001 | Auth module | User authentication | Credential theft | Phishing | High (8) | Full access | 8 | 6 | 4 | 192 | MFA + session management |
| CS-002 | Data store | Data confidentiality | SQL injection | Network input | Medium (5) | Data breach | 9 | 4 | 3 | 108 | Parameterized queries + WAF |
| CS-003 | Update mechanism | Integrity | Supply chain | Compromised update | Low (3) | Malware install | 10 | 2 | 7 | 140 | Code signing + integrity verification |

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Supply Chain Risk Management

Medical Device Supply Chain Risks

Risk Category	Description	Probability	Impact	Control Strategy
Single-source component	Critical component from sole supplier	Medium	Critical	Dual-source qualification, safety stock
Counterfeit components	Fraudulent parts entering supply chain	Low-Medium	Catastrophic	Supplier audits, incoming inspection, chain of custody
Supplier quality failure	Supplier QMS breakdown	Medium	High	Supplier qualification, periodic audits, quality agreements
Software dependency	Vulnerable or unsupported open-source library	High	Medium-High	SBOM management, vulnerability scanning, update policy
Geopolitical disruption	Sanctions, trade restrictions, supply interruption	Low-Medium	High	Geographic diversification, buffer inventory
Raw material shortage	Rare earth, specialty materials unavailability	Low	High	Alternative material qualification, forward contracts

Supply Chain Risk Assessment Workflow

Step 1: Supply Chain Mapping
        → Identify all direct suppliers (Tier 1)
        → Map critical Tier 2 and Tier 3 suppliers
        → Document component criticality (safety-critical, quality-critical, standard)

Step 2: Supplier Risk Scoring
        → Quality risk: past performance, certification status, audit results
        → Financial risk: stability, dependency on your business
        → Geographic risk: natural disaster, political stability
        → Cyber risk: supplier's information security posture
        → Concentration risk: single-source, regional concentration

Step 3: Risk Treatment
        → Critical suppliers: quality agreements, annual audits, dual-sourcing
        → High-risk suppliers: enhanced monitoring, contingency plans
        → Medium-risk suppliers: periodic review, performance metrics
        → Low-risk suppliers: standard purchasing controls

Step 4: Ongoing Monitoring
        → Supplier scorecard tracking (quality, delivery, responsiveness)
        → Annual supplier risk reassessment
        → Trigger-based reassessment (quality event, financial change, M&A)

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Post-Market Risk Monitoring Automation

Automated Signal Detection

Data Source	Automation Approach	Alert Threshold
Complaint database	Statistical process control (SPC) charts on complaint rates	>2 sigma deviation from baseline
Adverse event reports	NLP-based classification + trend analysis	Any serious event; trend >3x baseline
Literature monitoring	Automated PubMed/regulatory database searches	New publication on similar device adverse events
Field service data	Automated failure rate tracking	Failure rate exceeds design MTBF by >20%
Social media/forums	Keyword monitoring for device-related complaints	Cluster of similar complaints in 30-day window
Regulatory databases	MAUDE, EUDAMED vigilance module, BfArM monitoring	New recall or safety communication for similar device

Risk Management File Update Automation

Automated Trigger → Risk Review Decision Tree

New complaint received
    → Classify by hazard category (auto or manual)
    → Check: Known hazard?
        YES → Update frequency data → Recalculate risk level
                → Risk level changed? → Flag for risk management review
        NO  → New hazard identified → Initiate risk analysis
              → Estimate initial risk → Determine controls needed
              → Update risk management file

Trend threshold exceeded
    → Generate trend report with statistical analysis
    → Convene risk management review within 30 days
    → Update risk management file with new probability estimates
    → Evaluate if additional risk controls needed
    → If safety issue: initiate FSCA/field action assessment

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Cross-Reference: NIST Cybersecurity Framework Risk Assessment

Map ISO 14971 risk management to NIST CSF 2.0 for comprehensive risk coverage:

ISO 14971 Process	NIST CSF 2.0 Function	Integration Point
Hazard identification	Identify (ID.RA)	Combine clinical and cyber threat identification
Risk estimation	Identify (ID.RA-03, ID.RA-04)	Unified likelihood and impact scales
Risk evaluation	Identify (ID.RA-05, ID.RA-06)	Single risk register with combined acceptance criteria
Risk control	Protect (PR), Detect (DE)	Security controls as risk mitigations
Residual risk evaluation	Govern (GV.RM)	Combined residual risk statement
Post-production monitoring	Detect (DE.CM, DE.AE)	Unified monitoring for safety and security events

See also: ../information-security-manager-iso27001/SKILL.md for ISO 27001 security controls that serve as risk mitigations.

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Cross-Reference: DORA ICT Risk Management

For medical device companies operating as or supplying to financial entities in the EU, the Digital Operational Resilience Act (DORA, Regulation 2022/2554) adds ICT risk requirements:

DORA Requirement	ISO 14971 Integration	Action
ICT risk management framework (Art. 6)	Extend risk management plan to include ICT risks	Add ICT-specific risk categories to hazard analysis
ICT incident management (Art. 17)	Align with post-production monitoring	Unified incident classification and response
Digital operational resilience testing (Art. 24-27)	Complement risk control verification	Include penetration testing in verification activities
Third-party ICT risk (Art. 28-30)	Extend supply chain risk management	Assess ICT service providers per DORA requirements
Information sharing (Art. 45)	Enhance post-market information sources	Participate in threat intelligence sharing arrangements

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Enhanced FMEA with Cybersecurity Failure Modes

Combined Safety-Security FMEA Template

COMBINED SAFETY-SECURITY FMEA

Product: [Device Name]
Subsystem: [Subsystem]
Date: [Date]

TRADITIONAL SAFETY FAILURE MODES:
| ID | Item | Function | Failure Mode | Effect | S | Cause | O | Detection | D | RPN | Control |
|----|------|----------|--------------|--------|---|-------|---|-----------|---|-----|---------|
| FM-001 | Sensor | Measure vital sign | Incorrect reading | Wrong diagnosis | 8 | Calibration drift | 4 | Self-test | 3 | 96 | Auto-calibration |

CYBERSECURITY FAILURE MODES:
| ID | Asset | Security Objective | Threat | Attack Vector | Exploitability (O) | Impact (S) | Detection (D) | RPN | Security Control |
|----|-------|-------------------|--------|---------------|-------------------|-----------|---------------|-----|-----------------|
| CS-001 | Sensor data | Integrity | Data manipulation | MITM attack | 3 | 8 | 5 | 120 | TLS + data signing |
| CS-002 | Firmware | Integrity | Malicious update | Supply chain | 2 | 10 | 6 | 120 | Secure boot + code signing |
| CS-003 | User interface | Availability | DoS attack | Network flooding | 5 | 6 | 4 | 120 | Rate limiting + redundancy |

AI/ML FAILURE MODES (if applicable):
| ID | Component | ML Function | Failure Mode | Clinical Effect | S | Cause | O | Detection | D | RPN | ML Control |
|----|-----------|-------------|--------------|----------------|---|-------|---|-----------|---|-----|-----------|
| AI-001 | Classifier | Diagnose condition | False negative | Missed diagnosis | 9 | Distribution shift | 4 | Performance monitoring | 5 | 180 | Drift detection + human review |
| AI-002 | Classifier | Diagnose condition | Biased output | Health disparity | 8 | Unrepresentative training data | 3 | Subgroup analysis | 6 | 144 | Fairness constraints + diverse data |

COMBINED RPN THRESHOLDS:
>200: Critical — Immediate action required (all categories)
100-200: High — Action plan within 30 days
50-100: Medium — Monitor and consider action
<50: Low — Accept and monitor

Cybersecurity-Safety Interaction Analysis

Safety Control	Cybersecurity Impact	Mitigation
Alarm system	Alarm suppression via unauthorized access	Access control + alarm integrity monitoring
Fail-safe mode	Denial of service forcing perpetual safe mode	Rate limiting + redundant communication
Software update	Malicious update compromising safety function	Code signing + dual authorization + rollback capability
Data logging	Log tampering concealing safety events	Append-only logs + cryptographic integrity
User authentication	Lockout preventing emergency use	Break-glass procedures + local override

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Enhanced Risk Management — AI, Cybersecurity & Cross-Framework Integration

AI-Specific Risk Management

When managing risk for AI/ML medical devices, extend ISO 14971 with:

• AI Model Risk: Training data bias, model drift, adversarial attacks, explainability gaps
• Performance Degradation: Monitor for distribution shift, concept drift, and data quality issues
• Algorithmic Bias: Demographic parity, equalized odds, calibration across subgroups
• Human-AI Interaction Risks: Over-reliance, automation bias, alert fatigue, trust calibration
• Cross-reference: See eu-ai-act-specialist for EU AI Act risk classification

Cybersecurity Risk Integration (IEC 81001-5-1)

• Health Software Cybersecurity: IEC 81001-5-1 extends ISO 14971 for cybersecurity
• Threat Modeling: STRIDE methodology applied to medical device architecture
• Cybersecurity FMEA: Failure modes include unauthorized access, data breach, ransomware, supply chain attack
• Vulnerability Management: CVSS scoring integrated with ISO 14971 severity/probability matrix
• Cross-reference: See infrastructure-compliance-auditor for technical security checks

Supply Chain Risk Management

• Component Risk: Third-party software vulnerabilities (SBOM-based assessment)
• Supplier Risk: Single-source dependencies, geopolitical risks, quality history
• Cloud Risk: Data residency, service availability, vendor lock-in
• Cross-reference: See nis2-directive-specialist for NIS2 supply chain requirements

Cross-Framework Risk Mapping

Risk Area	ISO 14971	NIST CSF 2.0	DORA	NIS2
Risk Assessment	Clause 4	ID.RA	Art. 6	Art. 21.1
Risk Treatment	Clause 7	PR (all)	Art. 9	Art. 21.2
Monitoring	Clause 9	DE.CM	Art. 10	Art. 21.2.f
Incident Response	Clause 9	RS.MA	Art. 17	Art. 23
Continuous Improvement	Clause 10	ID.IM	Art. 13	Art. 21.2.f

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Troubleshooting

Problem	Likely Cause	Resolution
Risk matrix calculator returns "Invalid probability"	Probability value outside 1-5 range	Use integers 1-5 for probability (--probability) and 1-5 for severity (--severity). Run --list-criteria to display the full scale definitions.
FMEA RPN calculation produces unexpected results	Severity, occurrence, or detection values outside 1-10 range	FMEA mode (--fmea) requires --severity, --occurrence, and --detection values each in the 1-10 range. Values outside this range produce unreliable RPNs.
Risk level shows "Medium" but stakeholders expect "High"	Risk acceptability criteria differ from the tool's default 5x5 matrix	The default matrix follows common ISO 14971 practice. If your organization uses a custom risk matrix, adjust the risk acceptability criteria in your Risk Management Plan and document deviations.
Post-production risk data not triggering file updates	Review triggers not defined or too narrow	Define explicit triggers: any serious incident (immediate), new hazard identification (30 days), trend increase (60 days), design change (before implementation), and standards update (per transition period).
AI-specific hazards not captured in FMEA	Standard FMEA template lacks AI failure modes	Extend the FMEA with AI-specific failure modes: model bias, data drift, concept drift, adversarial inputs, automation complacency. Use the AI Risk Analysis Methodology section as a guide.
Cybersecurity threats not integrated into risk assessment	Threat modeling methodology not aligned to ISO 14971	Use STRIDE methodology for threat identification, then map each threat to an ISO 14971 harm pathway. Reference IEC 81001-5-1 for health software cybersecurity integration.
Benefit-risk analysis requested but no template available	The tool calculates risk levels but does not generate benefit-risk documents	The benefit-risk analysis is a narrative document per ISO 14971 Clause 8. Use the risk matrix outputs as quantitative inputs, then document clinical benefits vs. residual risks in the Risk Management Report.

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Success Criteria

• Risk Management Plan approved with defined scope, risk acceptability matrix, RACI chart, and post-production monitoring plan before design input phase
• 100% of ISO 14971 hazard categories analyzed (electrical, mechanical, thermal, radiation, biological, chemical, software, use error, environmental) with documented rationale for each
• All identified risks evaluated against the 5x5 acceptability matrix with no uncontrolled "Unacceptable" residual risks remaining
• Risk controls implemented following the priority hierarchy (inherent safety first, then protective measures, then information for safety) with verification records for every control
• Overall residual risk evaluated as acceptable or ALARP demonstrated, with benefit-risk analysis completed for any residual risks remaining in High territory
• Post-production risk monitoring operational with defined information sources, review triggers, and a documented process for updating the Risk Management File
• For AI/ML devices: AI-specific risk categories (bias, drift, adversarial inputs) assessed per BS/AAMI 34971:2023 or equivalent, with continuous performance monitoring thresholds defined

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Scope & Limitations

In Scope:

• ISO 14971:2019 risk management process implementation (planning, analysis, evaluation, control, residual risk, production/post-production)
• 5x5 risk matrix calculation and FMEA RPN scoring
• Hazard analysis methodology guidance (FMEA, FTA, HAZOP, Use Error Analysis, PHA)
• Risk control hierarchy application and verification planning
• Benefit-risk analysis framework
• Post-production risk monitoring and risk file update triggers
• AI/ML-specific risk management extensions (model bias, drift, adversarial inputs)
• Cybersecurity risk integration per IEC 81001-5-1
• Supply chain risk assessment methodology
• Cross-framework risk mapping (ISO 14971, NIST CSF, DORA, NIS2)

Out of Scope:

• Clinical investigation design or execution (risk management informs clinical strategy but does not execute studies)
• Software hazard analysis per IEC 62304 (the skill references software risk but detailed software lifecycle management requires IEC 62304 expertise)
• Biocompatibility testing or ISO 10993 evaluation (the skill identifies biological hazards but does not execute biocompatibility testing)
• Cybersecurity penetration testing or vulnerability scanning (use infrastructure-compliance-auditor for technical security testing)
• CAPA root cause analysis execution (use capa-officer for 5-Why, Fishbone, FTA, FMEA-based root cause investigation)
• Regulatory submission of risk management files (use regulatory-affairs-head for submission strategy and packaging)

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Integration Points

Skill	Integration
quality-manager-qms-iso13485	Risk management (Clause 7.1) integrates with QMS product realization planning; risk file is part of the Design History File
capa-officer	Post-market risk signals may trigger CAPA; CAPA root cause analysis methods (FMEA, FTA) overlap with risk analysis techniques
regulatory-affairs-head	Risk management file is required for FDA submissions and EU MDR Technical Documentation; benefit-risk analysis supports clinical evaluation
quality-documentation-manager	Risk management file and records must be controlled per document control procedures (Clause 4.2)
fda-consultant-specialist	FDA cybersecurity guidance (2025 update) requires integration of security risks into ISO 14971 processes for premarket submissions
infrastructure-compliance-auditor	Technical security controls validated by the infrastructure auditor serve as risk mitigations for cybersecurity threats in the risk assessment
nist-csf-specialist	NIST CSF risk assessment (ID.RA) maps to ISO 14971 hazard identification and risk estimation; unified risk register possible

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Tool Reference

risk_matrix_calculator.py

Calculates ISO 14971 risk levels and FMEA Risk Priority Numbers.

Flag	Required	Description
--probability	Yes (for ISO 14971 mode)	Probability level (1-5): 1=Improbable, 2=Remote, 3=Occasional, 4=Probable, 5=Frequent
--severity	Yes (for both modes)	Severity level: 1-5 for ISO 14971 mode, 1-10 for FMEA mode
--fmea	No	Switch to FMEA RPN calculation mode (requires --severity, --occurrence, --detection)
--occurrence	Yes (for FMEA mode)	Occurrence rating (1-10) for FMEA RPN calculation
--detection	Yes (for FMEA mode)	Detection rating (1-10) for FMEA RPN calculation
--interactive	No	Launch interactive mode for guided risk assessment
--list-criteria	No	Display probability, severity, and risk level criteria definitions