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SkillHub ClubWrite Technical DocsTech WriterSecurity

iso-13485-certification

Provides structured guidance and templates for creating ISO 13485 QMS documentation for medical device manufacturers. Includes gap analysis scripts, detailed procedure templates, and compliance checklists to help teams prepare for certification audits.

Packaged view

This page reorganizes the original catalog entry around fit, installability, and workflow context first. The original raw source lives below.

Stars
15,475
Hot score
99
Updated
March 20, 2026
Overall rating
A8.9
Composite score
7.8
Best-practice grade
N/A

Install command

npx @skill-hub/cli install k-dense-ai-claude-scientific-skills-iso-13485-certification
medical-devicequality-managementcomplianceregulatorydocumentation-templates

Repository

K-Dense-AI/claude-scientific-skills

Skill path: scientific-skills/iso-13485-certification

Provides structured guidance and templates for creating ISO 13485 QMS documentation for medical device manufacturers. Includes gap analysis scripts, detailed procedure templates, and compliance checklists to help teams prepare for certification audits.

Open repository

Best for

Primary workflow: Write Technical Docs.

Technical facets: Tech Writer, Security.

Target audience: Documentation teams looking for install-ready agent workflows..

License: Unknown.

Original source

Catalog source: SkillHub Club.

Repository owner: K-Dense-AI.

This is still a mirrored public skill entry. Review the repository before installing into production workflows.

What it helps with

  • Install iso-13485-certification into Claude Code, Codex CLI, Gemini CLI, or OpenCode workflows
  • Review https://github.com/K-Dense-AI/claude-scientific-skills before adding iso-13485-certification to shared team environments
  • Use iso-13485-certification for documentation workflows

Works across

Claude CodeCodex CLIGemini CLIOpenCode

Favorites: 0.

Sub-skills: 0.

Aggregator: No.