Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.
97
Pending
Does it follow best practices?
Impact
94%
1.09xAverage score across 6 eval scenarios
Passed
No known issues
FMEA with RPN and risk controls
FMEA column structure
100%
100%
RPN formula used
100%
100%
RPN threshold actions
60%
100%
risk_matrix_calculator.py invoked
41%
100%
All four components analyzed
100%
100%
Risk control hierarchy followed
100%
100%
Options considered documented
100%
70%
New hazards analyzed
100%
100%
Minimum failure mode coverage
100%
100%
S, O, D scales correct
100%
100%
Risk management plan and hazard analysis
Risk matrix P1-P5 and S1-S5
100%
100%
Correct risk level mapping
100%
100%
Risk level actions stated
87%
100%
All hazard categories addressed
100%
100%
Hazard analysis worksheet format
100%
100%
Plan scope and criteria sections
100%
100%
Plan responsibilities section
100%
100%
Plan verification and post-production sections
100%
100%
ALARP demonstration elements
62%
100%
Method selection matched to situation
100%
100%
Benefit-risk trigger identified
100%
100%
Intended use and misuse documented
100%
100%
Post-production monitoring and use error analysis
Vigilance immediate response
70%
100%
New hazard 30-day response
100%
100%
Trend increase 60-day response
25%
100%
Information sources with frequencies
100%
100%
Use error type classification
30%
60%
Memory error identified
16%
50%
Cognition error identified
16%
50%
Periodic review completeness
66%
100%
RM file update triggers
100%
100%
Use error risk controls proposed
100%
100%
Risk relevance determination
100%
100%
FTA and software hazard analysis
FTA top event defined
100%
100%
FTA uses AND/OR logic gates
100%
50%
Cut sets identified
100%
100%
Single points of failure documented
100%
100%
Software safety class assigned
100%
100%
Software failure mode types used
0%
40%
Software FMEA columns complete
80%
60%
Traceability chain documented
100%
100%
risk_matrix_calculator.py invoked
100%
100%
Software risk controls documented
50%
58%
HAZOP and risk control implementation records
HAZOP guide words applied
100%
100%
HAZOP worksheet format
100%
100%
HAZOP node design intent stated
100%
100%
Hazard IDs in H-XXX format
50%
100%
Multiple control options considered
100%
100%
Control hierarchy followed in selection
100%
100%
RC-XXX control IDs used
62%
100%
Control type classified
100%
100%
Verification method specified
100%
100%
New hazards from controls analyzed
100%
100%
Residual risk assessed post-control
87%
100%
Risk management report and benefit-risk analysis
RMR document number format
66%
66%
Required report sections present
83%
100%
Risk distribution table (before/after)
100%
100%
Controls breakdown by type
100%
100%
Cumulative residual risk addressed
60%
100%
Benefit-risk: primary benefit with evidence
100%
100%
Benefit-risk: state-of-the-art comparison
100%
100%
ALARP demonstration criteria referenced
100%
100%
Benefit-risk conclusion stated
100%
100%
Approval signatures section
75%
100%
Overall acceptability conclusion
100%
100%
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Table of Contents
If you maintain this skill, you can claim it as your own. Once claimed, you can manage eval scenarios, bundle related skills, attach documentation or rules, and ensure cross-agent compatibility.