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Iso 13485 Certification

Category: General  ·  Sub-category: general-misc  ·  Last updated:
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 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

What this skill does

Iso 13485 Certification is a community-contributed Claude Code skill in the general-misc sub-category. It ships as a SKILL.md file that Claude Code auto-discovers under ~/.claude/skills/iso-13485-certification/ and loads when your prompt matches the skill's trigger.

When to invoke it: 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 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

Who uses this skill

The Iso 13485 Certification Claude Code skill is built for Claude Code users and developers across all disciplines looking for general-purpose AI assistance. It's part of ClaudSkills (also referred to as Claude Skills or Claude Code Skills) — the open community-curated registry of 70,000+ SKILL.md files for Anthropic's Claude Code agent and the wider Claude ecosystem (Claude API, Claude Agent SDK).

How to install

Free

Manual install (2 steps)

mkdir -p ~/.claude/skills/iso-13485-certification
curl -L https://claudskills.com/skills/iso-13485-certification/SKILL.md \
  -o ~/.claude/skills/iso-13485-certification/SKILL.md

Or just download SKILL.md directly and drop it into ~/.claude/skills/iso-13485-certification/. Claude Code auto-discovers it on next session.

Skills live at ~/.claude/skills/iso-13485-certification/SKILL.md on macOS/Linux, or %USERPROFILE%\.claude\skills\iso-13485-certification\SKILL.md on Windows. See the full install guide for step-by-step instructions.

Pro

One-click install via the desktop app

The ClaudSkills desktop app installs any skill directly into ~/.claude/skills/ with one click — no terminal required. Pro starts at $9/mo or $149 lifetime.

Pro

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See pricing → Download desktop app

Attribution & license

Cite this skill

If you reference this skill in a blog post, paper, or documentation, you can cite it as:

APA
ClaudSkills. (2026). Iso 13485 Certification [Claude Code skill]. ClaudSkills. https://claudskills.com/skills/iso-13485-certification/
BibTeX
@misc{iso-13485-certification-2026,
  author    = {ClaudSkills},
  title     = {Iso 13485 Certification [Claude Code skill]},
  year      = {2026},
  publisher = {ClaudSkills},
  url       = {https://claudskills.com/skills/iso-13485-certification/}
}

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Part of ClaudSkills — the open registry for Claude Skills & Claude Code Skills.  ·  What's New  ·  Install guide  ·  About  ·  llms.txt

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