alterlab-iso13485

# ISO 13485 Certification Documentation Assistant ## Overview This skill helps medical device manufacturers prepare comprehensive documentation for ISO 13485:2016 certification. It provides tools, templates, references, and guidance to create, review, and gap-analyze all required Quality Management System (QMS) documentation. **What this skill provides:** - Gap analysis of existing documentation - Templates for all mandatory documents - Comprehensive requirements guidance - Step-by-step documentation creation - Identification of missing documentation - Compliance checklists **When to use this skill:** - Starting ISO 13485 certification process - Conducting gap analysis against ISO 13485 - Creating or updating QMS documentation - Preparing for certification audit - Transitioning from FDA QSR to QMSR - Harmonizing with EU MDR requirements ## Core Workflow ### 1. Assess Current State (Gap Analysis) **When to start here:** User has existing documentation and needs to identify gaps **Process:** 1. **Collect existing documentation:** - Ask user to provide directory of current QMS documents - Documents can be in any format (.txt, .md, .doc, .docx, .pdf) - Include any procedures, manuals, work instructions, forms 2. **Run gap analysis script:** ```bash python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json ``` 3. **Review results:** - Identify which required procedures are present vs. missing. The script checks the 26 always-...