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.
安装
npx skills add AlterLab-IEU/AlterLab-Academic-Skills --skill alterlab-iso13485npx skills add AlterLab-IEU/AlterLab-Academic-Skills --skill alterlab-iso13485 -a claude-code -gnpx skills add AlterLab-IEU/AlterLab-Academic-Skills --skill alterlab-iso13485 -a codex -ggemini skills install https://github.com/AlterLab-IEU/AlterLab-Academic-Skills.git --path skills/clinical-research/alterlab-iso13485gh skill install AlterLab-IEU/AlterLab-Academic-Skills alterlab-iso13485git 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