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iso-13485-certification

97 / 100 · Low risk

Fine to try.

By boisenoise/skills-collections (GitHub) · writing · 12 stars · scanned at commit 419c39f

Prepare and structurally review ISO 13485 QMS scope, controlled documentation, and local evidence manifests. Use for ISO 13485 certification-readiness documentation or for separating related FDA QMSR, MDSAP, and EU MDR/IVDR evidence boundaries; not for legal applicability, compliance, or certification decisions.

Works with any agent that supports SKILL.md skills.

What this skill can do

Install

Paste this into your terminal. It downloads exactly the version we scanned, not whatever is newest.

if [ -e ~/.agents/skills/'iso-13485-certification' ] || [ -L ~/.agents/skills/'iso-13485-certification' ]; then echo 'A skill folder named iso-13485-certification already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/boisenoise/skills-collections' "$d" && git -C "$d" checkout --quiet '419c39fde874b8baecbb36a397b967e0190a2ece' -- 'skills/kdense-iso-13485-certification' && mkdir -p ~/.agents/skills && cp -R "$d"/'skills/kdense-iso-13485-certification' ~/.agents/skills/'iso-13485-certification' && rm -rf "$d"; fi

Codex reads ~/.agents/skills directly. For Claude Code, Cursor, Copilot, Gemini CLI, Antigravity or OpenCode, also link it. For Claude Code: ln -s ~/.agents/skills/'iso-13485-certification' ~/.claude/skills/'iso-13485-certification' (other agents: ~/.cursor/skills, ~/.copilot/skills, ~/.gemini/skills, ~/.gemini/config/skills, ~/.config/opencode/skills). Or install through the finder skill, which does both.

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