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iso-13485-certification

Generate ISO 13485:2016 quality manuals, procedures, and gap analysis templates.

Updated Aug 23, 2026
Search Tags:#gap analysis#regulatory compliance#medical device#qms#iso 13485#quality manual
One-click install
npx skills add https://github.com/must1f/Dissertaion-Project --skill iso-13485-certification-must1f
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: iso-13485-certification
Source: https://github.com/must1f/Dissertaion-Project/tree/main/.agents/skills/iso-13485-certification
Command: npx skills add https://github.com/must1f/Dissertaion-Project --skill iso-13485-certification-must1f

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

Comprehensive toolkit to help medical device teams achieve ISO 13485:2016 certification by guiding gap analysis, Quality Manual creation, MDF development, and the 31 required procedures, with built-in references to regulatory requirements.

Core Features & Use Cases

  • Gap analysis templates and automated checks to identify ISO 13485 compliance gaps
  • Templates for Quality Manual, Medical Device File (MDF), and the 31 documented procedures
  • Step-by-step guidance to create, review, and align QMS documentation for certification audits
  • Reference library with ISO 13485 clauses and regulatory requirements (FDA QMSR, MDR, Health Canada)

Quick Start

Start by running a gap analysis on your current QMS documents, then generate a draft Quality Manual and core procedures.

Frequently Asked Questions about iso-13485-certification

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

FAQPage Schema
What is included in an ISO 13485 QMS starter kit?▼

An ISO 13485 QMS starter kit includes gap analysis templates, a Quality Manual, Medical Device File (MDF) templates, and the 31 required documented procedures to achieve certification.

How do I perform an ISO 13485 gap analysis on my current QMS?▼

Perform an ISO 13485 gap analysis by running automated checks against your current QMS documents to identify compliance gaps and generate policy-level guidance for remediation.

Does this ISO 13485 toolkit support FDA QMSR and EU MDR regulatory requirements?▼

Yes, the toolkit includes a reference library that aligns ISO 13485:2016 documentation with FDA QMSR, EU MDR, and Health Canada regulatory requirements as applicable.

What's the best way to generate a Quality Manual for medical device manufacturing?▼

Generate a Quality Manual for medical device manufacturing by completing a gap analysis first, then using the provided templates to draft the manual and align core procedures for certification audits.

Can I claim exclusions for certain ISO 13485 clauses in my Quality Manual?▼

Yes, the toolkit supports appropriate exclusions within your QMS documentation, allowing you to justify and document any ISO 13485 clauses that do not apply to your medical device operations.

How many documented procedures are required for ISO 13485:2016 certification?▼

ISO 13485:2016 certification requires 31 documented procedures, which this toolkit provides as ready-to-use templates alongside your Medical Device File and Quality Manual.

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