Can I use my existing documents with the gap analyzer?

Absolutely. The gap analyzer script can process existing documentation in various formats like Markdown, text, and Word to identify specific missing requirements.

What documents are included in the templates?

The toolkit includes templates for the Quality Manual, CAPA procedures, Document Control, Complaint Handling, Internal Audits, and all other mandatory ISO 13485 procedures.

How does this skill help with ISO 13485 certification?

It provides a structured workflow to assess your current documentation via gap analysis, offers templates for all required procedures, and guides you through creating a compliant Quality Manual.

Does it support the new FDA QMSR requirements?

Yes, the skill is designed to help manufacturers transition from the old FDA QSR to the new QMSR, which is harmonized with the ISO 13485:2016 standard.

ISO 13485 Certification Assistant

Name: ISO 13485 Certification Assistant
Author: Yezez9

byYezez9

0•

Learning & Documentation

Streamlines the creation, review, and gap analysis of Quality Management System documentation for medical device regulatory compliance.

This skill serves as a comprehensive toolkit for medical device manufacturers seeking ISO 13485:2016 certification. It provides an automated gap analysis engine to evaluate existing documentation, a full suite of templates for mandatory procedures (SOPs) and Quality Manuals, and detailed clause-by-clause guidance. Designed to support startups and established firms alike, the skill facilitates the transition to the FDA QMSR and harmonization with EU MDR requirements, ensuring that Quality Management Systems (QMS) are robust, audit-ready, and fully compliant with international standards.

Key Features

01Automated gap analysis script for existing QMS documentation

02Standardized templates for all 31 mandatory ISO 13485 procedures

03Prioritized action planning for certification audit preparation

04Structured framework for building Medical Device Files (MDF)

05Clause-by-clause requirements breakdown and implementation guidance

060 GitHub stars

Use Cases

01Harmonizing existing quality systems with FDA QMSR and EU MDR standards

02Building a compliant QMS from scratch for medical device startups

03Conducting internal audits and identifying missing documentation gaps

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add yezez9/research-agent iso-13485-certification

For use in Claude.ai and ChatGPT

Key Features

01Automated gap analysis script for existing QMS documentation

02Standardized templates for all 31 mandatory ISO 13485 procedures

03Prioritized action planning for certification audit preparation

04Structured framework for building Medical Device Files (MDF)

05Clause-by-clause requirements breakdown and implementation guidance

060 GitHub stars

Use Cases

01Harmonizing existing quality systems with FDA QMSR and EU MDR standards

02Building a compliant QMS from scratch for medical device startups

03Conducting internal audits and identifying missing documentation gaps

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add yezez9/research-agent iso-13485-certification

For use in Claude.ai and ChatGPT