Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485…
Install
npx skills add K-Dense-AI/scientific-agent-skills --skill iso-13485-certificationnpx skills add K-Dense-AI/scientific-agent-skills --skill iso-13485-certification -a claude-code -gnpx skills add K-Dense-AI/scientific-agent-skills --skill iso-13485-certification -a codex -ggemini skills install https://github.com/K-Dense-AI/scientific-agent-skills.git --path scientific-skills/iso-13485-certificationgh skill install K-Dense-AI/scientific-agent-skills iso-13485-certificationgit clone --depth 1 https://github.com/K-Dense-AI/scientific-agent-skills /tmp/K-Dense-AI__scientific-agent-skills
mkdir -p ~/.claude/skills ~/.agents/skills
cp -R /tmp/K-Dense-AI__scientific-agent-skills/scientific-skills/iso-13485-certification ~/.claude/skills/iso-13485-certification # Claude Code
cp -R /tmp/K-Dense-AI__scientific-agent-skills/scientific-skills/iso-13485-certification ~/.agents/skills/iso-13485-certification # Codex, Cursor, Gemini CLI, Copilot, OpenCode