Can this skill assist with FDA submissions?

Yes, it provides oversight and assembly guidance for 510(k), PMA, and De Novo documentation, ensuring all content meets technical templates and regulatory guidelines.

How does this skill help with ISO 13485 compliance?

It provides a systematic framework specifically designed for Clause 4.2.3, covering document classification, approval workflows, version control, and mandatory retention policies.

Does it support electronic signatures?

The skill includes frameworks for implementing 21 CFR Part 11 compliance, including audit trails, user authentication, and system validation controls for electronic records.

How is change management handled within this skill?

It utilizes a structured workflow involving change initiation, impact analysis, technical review, validation, and post-change monitoring to ensure no documentation gaps occur during updates.

Quality Documentation Manager

Name: Quality Documentation Manager
Author: pur3v4d3r

bypur3v4d3r

•

Learning & Documentation

Manages comprehensive quality document control and regulatory compliance for medical device organizations using systematic change management and configuration control.

About

The Quality Documentation Manager skill equips Claude with expert-level capabilities to design and oversee robust document control systems aligned with ISO 13485, EU MDR, and FDA standards. It provides a structured framework for the entire document lifecycle, from initial creation and approval workflows to multi-jurisdictional regulatory oversight and secure retention. By implementing advanced change control processes and 21 CFR Part 11 compliant electronic signature systems, this skill ensures that technical documentation remains accurate, traceable, and audit-ready in highly regulated environments.

Key Features

Comprehensive regulatory oversight for EU MDR, FDA 510(k), and international submissions
Implementation of 21 CFR Part 11 compliant electronic signature and record-keeping frameworks
Automated Document Control System (DMS) design based on ISO 13485 standards
Multi-language documentation management and linguistic validation strategies
Rigorous change control workflows with impact assessment and version synchronization
1 GitHub stars

Use Cases

Managing complex change requests and configuration control for existing product documentation
Preparing technical documentation packages for EU MDR or FDA regulatory submissions
Implementing a new electronic document management system (eDMS) for a medical device startup

About

Key Features

Comprehensive regulatory oversight for EU MDR, FDA 510(k), and international submissions
Implementation of 21 CFR Part 11 compliant electronic signature and record-keeping frameworks
Automated Document Control System (DMS) design based on ISO 13485 standards
Multi-language documentation management and linguistic validation strategies
Rigorous change control workflows with impact assessment and version synchronization
1 GitHub stars

Use Cases

Managing complex change requests and configuration control for existing product documentation
Preparing technical documentation packages for EU MDR or FDA regulatory submissions
Implementing a new electronic document management system (eDMS) for a medical device startup