Exact public version
risk-management-specialist v1
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.
5b4039002e4584e78ba5788df0045a9136cc6c75bcdf0a6d184cf2a668ad96f2Package contents
Manifest
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.
68b1622502dfcf5e4ac3ee727ae3df89c2408f080aa7de19aa83fc726439bca5- SKILL.md16,844 bytes
- references/iso14971-implementation-guide.md15,551 bytes
- references/risk-analysis-methods.md13,359 bytes
- references/risk-assessment-templates.md1,993 bytes
- scripts/fmea_analyzer.py16,237 bytes
- scripts/risk_matrix_calculator.py14,575 bytes