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iso-13485-certification

Generate ISO 13485:2016 QMS documentation templates and gap analysis guidance.

33.0k|3.2k|Updated Oct 19, 2025
Search Tags:#documentation#compliance#gap-analysis#qms#medical-device#iso-13485
One-click install
npx skills add https://github.com/K-Dense-AI/scientific-agent-skills --skill iso-13485-certification-k-dense-ai
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: iso-13485-certification
Source: https://github.com/K-Dense-AI/scientific-agent-skills/tree/main/scientific-skills/iso-13485-certification
Command: npx skills add https://github.com/K-Dense-AI/scientific-agent-skills --skill iso-13485-certification-k-dense-ai

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

Comprehensive toolkit to prepare ISO 13485:2016 certification documentation for medical device Quality Management Systems, including gap analysis, Quality Manual creation, procedure and work instruction development, Medical Device Files, and regulatory alignment. Also use when users mention medical device regulations, QMS certification, FDA QMSR, or EU MDR.

Core Features & Use Cases

  • Gap analysis with automated checks against ISO 13485:2016 requirements and references
  • Templates and references: Quality Manual template, CAPA template, Document Control template, and Medical Device File guidance
  • Guidance for regulatory alignment (FDA QMSR, EU MDR) and audit readiness
  • Practical workflows for starting from scratch, updating existing QMS, or preparing for certification

Quick Start

Read ISO 13485 requirements, run the gap analysis on your current documentation, then generate a Quality Manual from the templates and start drafting required procedures.

Frequently Asked Questions about iso-13485-certification

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

FAQPage Schema
How do I prepare ISO 13485 quality management system documentation for medical device compliance?▼

ISO 13485 documentation preparation involves running a gap analysis on current QMS practices, generating a Quality Manual, and drafting required procedures using structured templates to automate readiness for medical device manufacturers.

What is included in an ISO 13485 gap analysis for medical device manufacturers?▼

An ISO 13485 gap analysis evaluates current QMS documentation against 13485:2016 requirements, identifying missing procedures and providing automated checks with references to guide corrective actions before certification audits.

Can I use this to create a CAPA template and Medical Device Files for EU MDR compliance?▼

Yes, you can create CAPA templates and Medical Device Files for EU MDR compliance, as the toolkit provides specific regulatory alignment guidance for FDA QMSR transition and EU MDR requirements alongside standard QMS documentation.

Does this support updating an existing QMS for the FDA QMSR transition?▼

Yes, this supports updating an existing QMS for the FDA QMSR transition by offering practical workflows for modifying current documentation, ensuring regulatory alignment, and achieving audit readiness without starting from scratch.

What templates are available for ISO 13485 quality manual and document control?▼

Available templates for ISO 13485 include a Quality Manual template, CAPA template, and Document Control template, providing structured formatting to accelerate procedure development and work instruction drafting.

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