quality-documentation-manager

What problem does it solve?

This Skill helps medical device teams design and operate a robust Document Control System (DCS), manage regulatory documentation across jurisdictions, and implement change control and configuration management to support ISO 13485 compliance.

Core Features & Use Cases

• Document Control System Design: taxonomy, versioning, workflows, and lifecycle management for controlled documents.
• Regulatory Documentation Oversight: EU MDR, FDA, ISO standards, and multi-language/documentation requirements.
• Change Control & Configuration Management: end-to-end change management with impact analysis, approvals, and traceability.
• Document Management System (DMS) Implementation: planning and deployment guidance, with references to templates and integration.

Quick Start

Inspect the included references and templates, then run the example script to bootstrap a starter DMS plan. Example: python scripts/example.py