Does this skill support ISO 13485 standards?

Yes, it provides specific frameworks for Document Control System Design based on ISO 13485 Clause 4.2.3, ensuring systematic management and regulatory compliance.

Can it help with FDA 21 CFR Part 11?

Absolutely. The skill includes a comprehensive framework for implementing electronic signature systems, user authentication, and audit trail controls required for FDA compliance.

How does it handle change management?

It implements a robust Change Control Workflow that covers initiation, impact assessment, technical review, validation, and post-change monitoring.

Is it suitable for EU MDR documentation?

Yes, the skill offers oversight for Annex II and III Technical Documentation requirements under the EU Medical Device Regulation.

Quality Documentation Manager

Name: Quality Documentation Manager
Author: alirezarezvani

byalirezarezvani

•

1,040

Content Management

Manages comprehensive document control systems and regulatory compliance for medical device organizations using standardized quality management frameworks.

About

The Quality Documentation Manager skill equips Claude with the expertise required to oversee complex documentation lifecycles within highly regulated environments, specifically targeting the medical device industry. It provides structured guidance for ISO 13485 compliance, EU MDR technical documentation, FDA 510(k) submissions, and 21 CFR Part 11 electronic record requirements. Whether you are designing a document control architecture from scratch or managing intricate change control workflows, this skill ensures that documentation remains traceable, secure, and audit-ready across multiple global jurisdictions.

Key Features

ISO 13485-compliant document control system architecture and design
Multi-jurisdictional regulatory oversight for EU MDR and FDA submissions
Robust change control and configuration management workflows
21 CFR Part 11 compliant electronic signature and record frameworks
Automated documentation quality metrics and audit assessment tools
1,040 GitHub stars

Use Cases

Establishing a standardized document numbering and lifecycle system for new quality management systems.
Drafting and reviewing technical documentation packages for EU MDR or FDA regulatory submissions.
Implementing and validating electronic document management systems (DMS) for distributed engineering teams.

About

Key Features

ISO 13485-compliant document control system architecture and design
Multi-jurisdictional regulatory oversight for EU MDR and FDA submissions
Robust change control and configuration management workflows
21 CFR Part 11 compliant electronic signature and record frameworks
Automated documentation quality metrics and audit assessment tools
1,040 GitHub stars

Use Cases

Establishing a standardized document numbering and lifecycle system for new quality management systems.
Drafting and reviewing technical documentation packages for EU MDR or FDA regulatory submissions.
Implementing and validating electronic document management systems (DMS) for distributed engineering teams.