Risk Management Specialist
If you're building medical devices and need to follow ISO 14971, this walks you through the entire risk management lifecycle with actual workflows. You get risk analysis templates with probability and severity matrices, FMEA guidance, ALARP documentation requirements, and post-production monitoring setups. It's structured around the standard's phases: planning, analysis, evaluation, control, and post-production surveillance. The 5x5 risk matrix and decision trees are ready to use. Honestly most useful if you're starting from scratch or your current process is scattered across wikis and spreadsheets. Assumes you know the regulatory context already.
- skills.sh installs
- 136
- GitHub stars
- 1.1K
- last updated
- Aug 21, 2026
Install
$ npx -y skills add borghei/claude-skills --skill risk-management-specialist --agent claude-codeInstalls into .claude/skills of the current project.
Files
Risk Management Specialist
ISO 14971:2019 risk management implementation throughout the medical device lifecycle — planning, hazard analysis, risk evaluation, risk control, residual-risk assessment, and post-production monitoring — extended for AI/ML, cybersecurity (IEC 81001-5-1), supply chain, and cross-framework alignment (NIST CSF, DORA, NIS2).
Core Capabilities
- Risk management planning — scope, 5x5 acceptability matrix, RACI, verification and post-production planning
- Risk analysis & evaluation — hazard identification across 9 categories, P1-P5 / S1-S5 estimation, ALARP, benefit-risk triggers
- Risk control — priority hierarchy (inherent safety → protective measures → information for safety), verification methods, residual-risk evaluation
- Post-production monitoring — information sources, review triggers, RM-file update procedures, periodic review
- Extended domains — AI/ML risk (bias, drift, adversarial inputs), health-software cybersecurity, supply chain risk, cross-framework mapping
When to Use
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- Repository
- github.com/borghei/claude-skills
- First seen
- Jun 3, 2026
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