skills.rest
crazymsn
crazymsnCOMMUNITY
Explore all skills by this author →
WebsiteGitHub

iso-13485-certification

Identify ISO 13485:2016 documentation gaps and provide templates and guidance.

22|4|Updated May 25, 2026
Search Tags:#documentation#gap-analysis#iso13485#qms#medical-device#mdf#qmsr
One-click install
npx skills add https://github.com/crazymsn/academic-skills --skill iso-13485-certification-crazymsn
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: iso-13485-certification
Source: https://github.com/crazymsn/academic-skills/tree/main/academic-skills/iso-13485-certification
Command: npx skills add https://github.com/crazymsn/academic-skills --skill iso-13485-certification-crazymsn

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) and assets (resource) components.

What problem does it solve?

This skill helps medical device manufacturers prepare ISO 13485:2016 documentation by identifying gaps, providing templates, and guiding the creation of a Quality Manual, Medical Device Files, and required procedures.

Core Features & Use Cases

  • Gap analysis against ISO 13485:2016 requirements
  • Templates for Quality Manual, Medical Device File, CAPA procedures, and the 31 documented procedures
  • Step-by-step guidance for documentation generation, risk management integration, and regulatory alignment
  • References to ISO 13485 requirements, FDA QMSR transitions, and EU MDR guidance

Quick Start

Provide your current QMS documents and request a gap analysis against ISO 13485 to identify missing documentation.

Frequently Asked Questions about iso-13485-certification

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I perform an ISO 13485 gap analysis for my medical device QMS documentation?▼

To perform an ISO 13485 gap analysis, provide your current QMS documents to identify missing documentation against ISO 13485:2016 requirements, which reveals the exact templates and procedures needed for compliance.

What templates are required for ISO 13485:2016 quality manual and medical device file creation?▼

ISO 13485:2016 requires templates for a Quality Manual, Medical Device File, CAPA procedures, risk management, work instructions, and 31 mandatory documented procedures to establish full QMS compliance.

Does ISO 13485 documentation align with FDA QMSR and EU MDR regulatory transitions?▼

Yes, ISO 13485 documentation aligns with FDA QMSR transitions and EU MDR guidance by integrating regulatory requirements into your quality manual and standard operating procedures.

Can I use this gap analysis approach for a medical device startup starting ISO 13485 from scratch?▼

Yes, medical device manufacturers starting ISO 13485 can use gap analysis to generate the 31 mandatory documented procedures, Medical Device Files, and work instructions from ready templates.

What is the best way to integrate risk management into ISO 13485 QMS procedures?▼

The best way to integrate risk management into ISO 13485 QMS procedures is by using step-by-step guidance to align risk management processes with your documented procedures and Medical Device Files.

Related Skills

Explore More Legal & Compliance Skills→
biomaps-infrabiomaps-infra

workflow-iso-13485-certification

Create ISO 13485:2016 QMS documentation and perform gap analysis.

Official
Advanced
swaruplabswaruplab
94

iso-13485-certification

Identify ISO 13485:2016 documentation gaps and guide QMS creation.

Community
Advanced
felixboehmfelixboehm

iso-13485-certification

Prepare ISO 13485:2016 certification documentation for medical device manufacturers.

Community
Advanced
Hung-3008Hung-3008
1

iso-13485-certification

Assemble and validate ISO 13485:2016 QMS documentation for medical-device manufacturers.

Community
Advanced