Risk Management Specialist | Skills Pool
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.
borghei 92 Sterne 30.03.2026 Beruf Kategorien Finanzen & Investitionen ISO 14971:2019 risk management implementation throughout the medical device lifecycle.
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Risk Management Specialist npx skillvault add borghei/borghei-claude-skills-ra-qm-team-risk-management-specialist-skill-md
Sterne 92
Aktualisiert 30.03.2026
Beruf
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
Define intended use and reasonably foreseeable misuse:
Medical indication
Patient population
User population
Use environment
Select analysis method(s):
FMEA for component/function analysis
FTA for system-level analysis
HAZOP for process deviations
Use Error Analysis for user interaction
Identify hazards by category:
Energy hazards (electrical, mechanical, thermal)
Biological hazards (bioburden, biocompatibility)
Chemical hazards (residues, leachables)
Operational hazards (software, use errors)
Determine hazardous situations:
Sequence of events
Foreseeable misuse scenarios
Single fault conditions
Estimate probability of harm (P1-P5)
Estimate severity of harm (S1-S5)
Document in hazard analysis worksheet
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
Risk Evaluation Workflow Evaluate risks against acceptability criteria.
Workflow: Evaluate Identified Risks
Calculate initial risk level from probability × severity
Compare to risk acceptability criteria
For each risk, determine:
Acceptable: Document and accept
ALARP: Proceed to risk control
Unacceptable: Mandatory risk control
Document evaluation rationale
Identify risks requiring benefit-risk analysis
Complete benefit-risk analysis if applicable
Compile risk evaluation summary
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
Risk Control Workflow Implement and verify risk control measures.
Workflow: Implement Risk Controls
Identify risk control options:
Inherent safety by design (Priority 1)
Protective measures in device (Priority 2)
Information for safety (Priority 3)
Select optimal control following hierarchy
Analyze control for new hazards introduced
Document control in design requirements
Implement control in design
Develop verification protocol
Execute verification and document results
Evaluate residual risk with control in place
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
Identify information sources:
Customer complaints
Service reports
Vigilance/adverse events
Literature monitoring
Clinical studies
Establish collection procedures
Define review triggers:
New hazard identified
Increased frequency of known hazard
Serious incident
Regulatory feedback
Analyze incoming information for risk relevance
Update risk management file as needed
Communicate significant findings
Conduct periodic risk management review
Validation: Information sources monitored; file current; reviews completed per schedule
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
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: _______
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
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 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
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)
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 |
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)
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
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.
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
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
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 gapsPerformance Degradation: Monitor for distribution shift, concept drift, and data quality issuesAlgorithmic Bias: Demographic parity, equalized odds, calibration across subgroupsHuman-AI Interaction Risks: Over-reliance, automation bias, alert fatigue, trust calibrationCross-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 cybersecurityThreat Modeling: STRIDE methodology applied to medical device architectureCybersecurity FMEA: Failure modes include unauthorized access, data breach, ransomware, supply chain attackVulnerability Management: CVSS scoring integrated with ISO 14971 severity/probability matrixCross-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 historyCloud Risk: Data residency, service availability, vendor lock-inCross-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
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.
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
Scope & Limitations
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)
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)
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
risk_matrix_calculator.py Calculates ISO 14971 risk levels and FMEA Risk Priority Numbers.
Flag Required Description --probabilityYes (for ISO 14971 mode) Probability level (1-5): 1=Improbable, 2=Remote, 3=Occasional, 4=Probable, 5=Frequent --severityYes (for both modes) Severity level: 1-5 for ISO 14971 mode, 1-10 for FMEA mode --fmeaNo Switch to FMEA RPN calculation mode (requires --severity, --occurrence, --detection) --occurrenceYes (for FMEA mode) Occurrence rating (1-10) for FMEA RPN calculation --detectionYes (for FMEA mode) Detection rating (1-10) for FMEA RPN calculation --interactiveNo Launch interactive mode for guided risk assessment --list-criteriaNo Display probability, severity, and risk level criteria definitions
02
Risk Management Planning Workflow
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Energy Procurement Codified expertise for electricity and gas procurement, tariff optimization, demand charge management, renewable PPA evaluation, and multi-facility energy cost management. Informed by energy procurement managers with 15+ years experience at large commercial and industrial consumers. Includes market structure analysis, hedging strategies, load profiling, and sustainability reporting frameworks. Use when procuring energy, optimizing tariffs, managing demand charges, evaluating PPAs, or developing energy strategies.
Finanzen & Investitionen
Carrier Relationship Management Codified expertise for managing carrier portfolios, negotiating freight rates, tracking carrier performance, allocating freight, and maintaining strategic carrier relationships. Informed by transportation managers with 15+ years experience. Includes scorecarding frameworks, RFP processes, market intelligence, and compliance vetting. Use when managing carriers, negotiating rates, evaluating carrier performance, or building freight strategies.