What problem does it solve?
This Skill helps medical device organizations prepare ISO 13485:2016 Quality Management System documentation by identifying missing required artifacts, explaining relevant clauses, and producing draft-ready core documents and templates.
Core Features & Use Cases
- ISO 13485 gap analysis: Analyze an existing documentation directory to produce a gap report (what exists, what’s missing, and how to prioritize next steps).
- Clause-by-clause understanding: Use the provided references to explain ISO 13485 requirements in practical, plain-language terms.
- Template-based document creation: Generate key documents such as a Quality Manual, CAPA procedure, and Document Control procedure by adapting templates and ensuring required sections are complete.
- Medical Device File (MDF) support: Guide the creation and content requirements of an MDF for each device type/family, including risk management and verification/validation information.
Use cases
- Starting ISO 13485 documentation from scratch for a medical device QMS.
- Running a targeted remediation plan when you already have some policies/procedures but don’t know what’s missing.
- Preparing for a certification audit by validating completeness and readiness of your QMS documentation set.
Quick Start
Ask the Skill to perform a gap analysis on your current QMS documentation directory and generate a prioritized ISO 13485 action plan report.
