Is this skill suitable for EU MDR compliance?

While focused on the ISO 13485 QMS foundation, it provides the core documentation and Medical Device File structure necessary to support technical file requirements for EU MDR.

Can it generate a full Quality Manual?

Yes, the skill provides a structured template and clause-by-clause guidance to help you customize a Quality Manual tailored to your specific organization, product scope, and exclusions.

How does this skill help with gap analysis?

It utilizes a built-in gap analyzer script to scan your local documentation directory, identifying which of the 31 required ISO 13485 procedures are present and highlighting missing elements.

Which procedures are included in the templates?

The toolkit includes templates for all mandatory procedures required by the standard, including CAPA, Document Control, Complaint Handling, Internal Audits, and Management Review.

Does this support FDA QMSR requirements?

Yes, the documentation patterns and Medical Device File (MDF) guidance are specifically designed to help manufacturers harmonize their QMS with both ISO 13485:2016 and the FDA's Quality System Management Regulation (QMSR).

ISO 13485 Certification Assistant

About

This skill serves as a comprehensive toolkit for medical device manufacturers seeking ISO 13485:2016 certification or aligning with FDA QMSR and EU MDR regulations. It automates initial assessments via a gap analysis script, provides structured templates for all 31 mandatory procedures—including CAPA, Internal Audits, and Risk Management—and guides users through the creation of a compliant Quality Manual and Medical Device Files (MDF). Whether starting from scratch or preparing for an audit, this assistant ensures all regulatory requirements are met with precise, domain-specific guidance and professional documentation patterns.

Key Features

Clause-by-clause ISO 13485:2016 requirement references and plain-language explanations
Automated gap analysis for existing Quality Management System (QMS) documentation
6,149 GitHub stars
Structural guidance for Medical Device Files (MDF) to meet international standards
Guided creation of Quality Manuals with specific sections for scope and exclusions
Professional templates for all 31 mandatory procedures including CAPA and Document Control

Use Cases

Conducting a pre-audit gap analysis on existing quality system documents to identify missing requirements
Generating a complete set of Standard Operating Procedures (SOPs) for a medical device startup
Transitioning an existing QMS from FDA QSR to the new QMSR standards for global harmonization

About

Key Features

Clause-by-clause ISO 13485:2016 requirement references and plain-language explanations
Automated gap analysis for existing Quality Management System (QMS) documentation
6,149 GitHub stars
Structural guidance for Medical Device Files (MDF) to meet international standards
Guided creation of Quality Manuals with specific sections for scope and exclusions
Professional templates for all 31 mandatory procedures including CAPA and Document Control

Use Cases

Conducting a pre-audit gap analysis on existing quality system documents to identify missing requirements
Generating a complete set of Standard Operating Procedures (SOPs) for a medical device startup
Transitioning an existing QMS from FDA QSR to the new QMSR standards for global harmonization

ISO 13485 Documentation Assistant

ISO 13485 Documentation Assistant

About

Key Features

Use Cases

About

Key Features

Use Cases