Built for HealthTech and MedTech QMR roles under ISO 13485. This handles the table stakes: prepping management reviews with all the required inputs from Clause 5.6, tracking quality KPIs like first pass yield and CAPA effectiveness, and documenting accountability matrices for Notified Body inspections. The workflow templates are thorough, covering everything from audit scheduling to customer complaint trending. It's structured more like a compliance handbook than a conversational agent, which honestly makes sense given FDA and regulatory bodies expect specific evidence trails. If you're running a quality system and need the documentation framework locked down, this gives you the scaffolding.
npx skills add https://github.com/borghei/claude-skills --skill quality-manager-qmr