6 skills · sorted by relevance
Routes regulatory and quality management requests to one of 15 specialist skills. Helps HealthTech and MedTech teams select the right workflow for audits, medical device regulations, information security, privacy, or AI compliance.
Builds quality into operations — defining standards, catching defects at the right point, root cause analysis, and continuous improvement. Use this to reduce a defect or error rate, design quality controls into a process, run a root cause analysis, respond to a customer quality complaint, or set up quality metrics that drive behavior.
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Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech. Use for management reviews, quality objectives and KPIs, quality culture, and Notified Body / FDA inspection prep per ISO 13485 Clause 5.5.2.
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Design a GxP training programme covering training needs analysis by role, curriculum design (regulatory awareness, system-specific, data integrity), competency assessment criteria, training record retention, and retraining triggers for SOP revisions and incidents. Use when a new validated system requires user training before go-live, an audit finding cites inadequate training, organisational changes introduce new roles, a periodic programme review is due, or inspection preparation requires demonstrating training adequacy.
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When the user wants to optimize aerospace and defense supply chains, manage long lead-time components, handle MRO operations, or ensure AS9100 compliance. Also use when the user mentions "aerospace supply chain," "aviation manufacturing," "MRO supply chain," "AS9100," "aircraft parts," "defense procurement," "AOG support," "airworthiness," "ITAR compliance," "aerospace certification," or "aviation aftermarket." For general manufacturing, see production-scheduling. For quality, see quality-management.
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12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
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