Quality Documentation Manager

If you're dealing with medical device documentation where ISO 13485 compliance isn't optional, this handles the full document control lifecycle from creation through disposal. It covers regulatory submission packages for FDA 510(k)s and EU MDR technical documentation, implements change control workflows with impact assessments, and manages 21 CFR Part 11 electronic signature validation. The multi-jurisdictional documentation framework is solid for coordinating across FDA, Health Canada, and TGA requirements simultaneously. Best for organizations that need systematic document control beyond basic file management, especially when you're managing design history files, risk management documentation, and post-market surveillance records that auditors will scrutinize.

skills.sh installs: 971
GitHub stars: 33.2K
last updated: Aug 21, 2026

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Install

$ npx -y skills add davila7/claude-code-templates --skill quality-documentation-manager --agent claude-code

Installs into .claude/skills of the current project.

Files

Senior Quality Documentation Manager

Expert-level quality documentation management with comprehensive document control system design, regulatory documentation oversight, change management, and configuration control for medical device organizations.