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iso-13485-certification

Generate ISO 13485:2016 QMS documentation and gap analysis reports.

Updated Aug 23, 2026
Search Tags:#gap analysis#regulatory compliance#medical device#iso 13485#capa#quality manual#qms documentation
One-click install
npx skills add https://github.com/gabrielvuksani/wotann --skill iso-13485-certification-gabrielvuksani
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: iso-13485-certification
Source: https://github.com/gabrielvuksani/wotann/tree/main/skills/scientific/iso-13485-certification
Command: npx skills add https://github.com/gabrielvuksani/wotann --skill iso-13485-certification-gabrielvuksani

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

The Skill solves the problem of figuring out what medical device Quality Management System documentation ISO 13485 requires and then generating, validating, and gap-checking that documentation efficiently for certification readiness.

Core Features & Use Cases

  • ISO 13485 gap analysis for existing QMS documents: Evaluate a provided documents folder against expected ISO 13485:2016 procedures and key quality-system documents, producing a prioritized report.
  • Clause-by-clause requirement guidance and document planning: Explain ISO 13485 requirements in plain language and map them to the appropriate Quality Manual content and mandatory procedure set.
  • Template-driven creation of key QMS documents: Produce a Quality Manual and example procedures (e.g., CAPA, document control) using structured templates and guidance.

Quick Start

Use the iso-13485-certification skill to run a gap analysis on your current QMS documentation by pointing it at your existing documents directory and requesting the highest-priority missing procedures and next-step action plan.

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 on my existing QMS documentation?▼

To perform an ISO 13485 gap analysis, point the skill at your existing QMS documents directory. It scans your files against medical device regulatory compliance clauses and generates a prioritized report of missing mandatory procedures.

What ISO 13485 mandatory procedures do I need for medical device certification?▼

ISO 13485 medical device certification requires mandatory procedures like CAPA and document control. The skill maps clause requirements in plain language to the appropriate Quality Manual content and necessary procedure set.

How do I check my QMS folder for missing medical device regulatory compliance documents?▼

You check a QMS folder by running the bundled gap analyzer script against it. This evaluates your existing files for missing medical device regulatory compliance documents and outputs a next-step action plan.

Does this skill interpret ISO 13485 clause requirements for my Quality Manual content?▼

Yes, the skill interprets ISO 13485 clause requirements in plain language. It maps these requirements directly to appropriate Quality Manual content and mandatory procedures for your medical device QMS.

Can I use this for ISO 13485 certification onboarding with no existing QMS?▼

Yes, you can use this for ISO 13485 certification onboarding. The skill generates foundational QMS documentation from templates and provides clause-by-clause guidance even if you are starting without an existing QMS.

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