Writing & Documentation
Real file from a public repo · synced Aug 23, 2026
iso-13485-certification
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
Claude CodeCursorCodex CLIGitHub CopilotGemini CLI
Install in three steps
- 1
Download the ZIP
One file per agent, plus INSTALL.md with the exact paths below.
- 2
Claude Code: copy SKILL.md into your skills folder
.claude/skills/iso-13485-certification/SKILL.md # this project ~/.claude/skills/iso-13485-certification/SKILL.md # every project
- 3
Other agents: use the matching file
skill.mdc goes in Cursor’s .cursor/rules/. AGENTS.md works as GitHub Copilot instructions, a legacy .cursorrules, or a Codex / Gemini CLI instructions file.
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