Does this skill handle FDA QMSR requirements?

Yes, it includes guidance for harmonizing ISO 13485 documentation with the latest FDA Quality Management System Regulation (QMSR) and EU MDR requirements.

What mandatory documents are covered?

It provides templates and guidance for all 31 required ISO 13485 procedures, including CAPA, Document Control, Internal Audits, and the Quality Manual.

Who is this skill designed for?

It is designed for medical device manufacturers, quality managers, and regulatory affairs professionals who need to build or maintain a compliant QMS.

Can it analyze my existing documents?

Yes, the skill includes a gap analysis workflow that can review your current document directory to identify missing mandatory procedures or non-compliant sections.

ISO 13485 Compliance Toolkit

Name: ISO 13485 Compliance Toolkit
Author: Sologa

bySologa

Productivity & Workflow

Guides medical device manufacturers through ISO 13485 certification with automated gap analysis, policy templates, and comprehensive QMS documentation support.

About

The ISO 13485 Certification Documentation Assistant is a specialized toolkit designed to streamline the complex process of establishing a Quality Management System (QMS) for medical devices. It enables users to conduct automated gap analyses on existing files, generate clause-by-clause compliant documentation using standardized templates, and ensure alignment with global standards like FDA QMSR and EU MDR. Whether starting from scratch or preparing for a certification audit, this skill provides the structured workflow and regulatory expertise needed to manage Quality Manuals, CAPA procedures, and Medical Device Files (MDF) with confidence.

Key Features

0 GitHub stars
Standardized templates for all 31 mandatory ISO 13485 procedures
Structured Quality Manual and Medical Device File (MDF) generation
Cross-reference guidance for FDA QMSR and EU MDR harmonization
Prioritized action planning for certification audit readiness
Automated gap analysis of existing QMS documentation

Use Cases

Conducting a gap analysis on legacy documentation before a certification audit
Establishing a new ISO 13485:2016 Quality Management System for a MedTech startup
Transitioning a quality system from FDA QSR to the harmonized QMSR standards

About

Key Features

0 GitHub stars
Standardized templates for all 31 mandatory ISO 13485 procedures
Structured Quality Manual and Medical Device File (MDF) generation
Cross-reference guidance for FDA QMSR and EU MDR harmonization
Prioritized action planning for certification audit readiness
Automated gap analysis of existing QMS documentation

Use Cases

Conducting a gap analysis on legacy documentation before a certification audit
Establishing a new ISO 13485:2016 Quality Management System for a MedTech startup
Transitioning a quality system from FDA QSR to the harmonized QMSR standards