Design Failure Mode and Effects Analysis (DFMEA) skill for systematic design risk identification
Generates systematic design risk analyses and FMEA worksheets for medical device development following ISO 14971.
npx claudepluginhub a5c-ai/babysitterThis skill is limited to using the following tools:
The Design FMEA Generator Skill facilitates systematic identification and evaluation of potential design failure modes for medical devices, supporting ISO 14971 risk management through structured DFMEA methodology.
This skill integrates with the following processes:
design-fmea-generator:
rating-scales:
severity: 1-10
occurrence: 1-10
detection: 1-10
risk-thresholds:
rpn-action-limit: 100
severity-critical: 9
output-formats:
- worksheet
- summary-report
- action-tracker
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