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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. 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

1.09x
Quality

Pending

Does it follow best practices?

Impact

94%

1.09x

Average score across 6 eval scenarios

SecuritybySnyk

Passed

No known issues

SKILL.md
Quality
Evals
Security

Evaluation results

97%

8%

Infusion Pump Flow Control FMEA

FMEA with RPN and risk controls

Criteria
Without context
With context

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%

100%

4%

Risk Management Planning for a Novel Glucose Monitoring Patch

Risk management plan and hazard analysis

Criteria
Without context
With context

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%

90%

20%

Post-Market Risk Review for an Insulin Delivery System

Post-production monitoring and use error analysis

Criteria
Without context
With context

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%

81%

-1%

Infusion Pump Software Safety Analysis

FTA and software hazard analysis

Criteria
Without context
With context

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%

100%

8%

Drug Delivery Process HAZOP and Risk Controls

HAZOP and risk control implementation records

Criteria
Without context
With context

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%

98%

8%

Pre-Market Risk Management Report for Cardiac Monitor

Risk management report and benefit-risk analysis

Criteria
Without context
With context

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%

Repository
alirezarezvani/claude-skills
Evaluated
Agent
Claude Code
Model
Claude Sonnet 4.6

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