Iso 13485 Certification

---
name: iso-13485-certification
description: Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
license: MIT license
metadata: {"version": "1.0", "skill-author": "K-Dense Inc."}
---

# 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… load the full skill through Skill Me