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.
npx skills add https://github.com/borghei/claude-skills --skill risk-management-specialist