Skill UI

This router bundles 15 specialized compliance skills crucial for HealthTech and MedTech organizations. It provides structured guidance across major global regulations, including ISO 13485 QMS, EU MDR, FDA submissions, GDPR, and the EU AI Act. Use this when a compliance request is complex and needs to be accurately directed to a specific technical skill area (e.g., risk management, CAPA, data security).

The GCP Organization Policy Service allows administrators to enforce centralized security guardrails and governance policies across an entire resource hierarchy (organization, folder, project). By defining constraints (List, Boolean, Custom), users can restrict risky resource configurations, ensuring compliance with internal security standards and external regulations. Ideal for security architecture, compliance checks, and cloud governance implementation.

A comprehensive toolkit for medical device manufacturers seeking ISO 13485 certification. This skill guides users through gap analysis, creating mandatory Quality Management System (QMS) documentation, and ensuring compliance with global medical device regulations (e.g., EU MDR, FDA QMSR). It provides templates, guidance, and structured processes for foundational QMS documents like Quality Manuals and CAPA procedures.