Alterlab Iso13485

AlterLab Creative Technologies Laboratory

Prepares ISO 13485 certification documentation for medical device Quality Management Systems (QMS) — gap analysis of existing documentation, Quality Manuals, required procedures and work instructions, and Medical Device Files.

Install

npx skills add AlterLab-IEU/AlterLab-Academic-Skills --skill alterlab-iso13485

npx skills add AlterLab-IEU/AlterLab-Academic-Skills --skill alterlab-iso13485 -a claude-code -g

npx skills add AlterLab-IEU/AlterLab-Academic-Skills --skill alterlab-iso13485 -a codex -g

gemini skills install https://github.com/AlterLab-IEU/AlterLab-Academic-Skills.git --path skills/clinical-research/alterlab-iso13485

gh skill install AlterLab-IEU/AlterLab-Academic-Skills alterlab-iso13485

git clone --depth 1 https://github.com/AlterLab-IEU/AlterLab-Academic-Skills /tmp/AlterLab-IEU__AlterLab-Academic-Skills
mkdir -p ~/.claude/skills ~/.agents/skills
cp -R /tmp/AlterLab-IEU__AlterLab-Academic-Skills/skills/clinical-research/alterlab-iso13485 ~/.claude/skills/alterlab-iso13485   # Claude Code
cp -R /tmp/AlterLab-IEU__AlterLab-Academic-Skills/skills/clinical-research/alterlab-iso13485 ~/.agents/skills/alterlab-iso13485   # Codex, Cursor, Gemini CLI, Copilot, OpenCode

Install

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