medical-qms-tools

What problem does it solve?

This Skill assists users in navigating the complexities of medical device quality management system (QMS) documentation, helping to plan, review, and gap-assess documentation against regulatory standards.

Core Features & Use Cases

• QMS Gap Assessment: Evaluate existing documentation against ISO 13485 and FDA QMSR.
• Documentation Planning: Assist in creating or reviewing Quality Manuals, SOPs, CAPAs, and other critical QMS documents.
• Audit Preparation: Generate checklists for audit readiness.
• Use Case: A startup developing a new diagnostic device needs to ensure their Quality Manual and design control procedures meet FDA requirements. This Skill can help them map their current documentation to the relevant clauses and identify any gaps.

Quick Start

Use the medical-qms-tools skill to gap-assess our current design control documentation against ISO 13485.