Agent skill · product strategy · aiskillstore
iso-13485-certification
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.
Why this skill is useful
Adds executable scripts for gap analysis and comprehensive templates for ISO 13485 documentation that are not commonly available.
What it needs
Requires python installed locally. About 11k tokens when loaded. Last updated 2026-08-07. 405 stars on the source repository.
What this skill does
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: 3. Review results: Identify which of the 31 required procedures are present Identify missing key documents (Quality Manual, MDF, etc.) Calculate compliance percentage Prioritize missing documentation 4. Present findings to user: Summarize what exists Clearly list what's missing Provide prioritized action plan Estimate effort required Output: Comprehensive gap analysis report with prioritized action items 2. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills aiskillstore/iso-13485-certification