Iso 13485 Certification

Q: What is a Claude Code skill and how does the Iso 13485 Certification skill fit in?

A Claude Code skill is a SKILL.md file that lives under ~/.claude/skills/<name>/ and tells the Claude Code CLI agent how to perform a specific task (instructions, prompts, allowed tools). Skills are auto-discovered at session start. Iso 13485 Certification is one of 67,000+ skills indexed in the open ClaudSkills catalog, classified under the General category. Learn more at https://claudskills.com/learn/what-is-skill-md/.

Category: General · Sub-category: general-misc · Last updated: 2026-05-21

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.

Security AStatic scan found no risk patternsHow grading works ›

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 146,000+ 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.

📱 Install from your phone or desktop Telegram

Open @claudskills_bot on Telegram, tap Open Desktop App, and the desktop app installs this skill for you. Or share the bot link with a colleague — they get the same one-tap install. Learn more →

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

For the full experience including quality scoring and one-click install features for each skill — upgrade to Pro.

See pricing → Download desktop app

Frequently asked questions

How do I install the Iso 13485 Certification Claude Code skill?

Install via the ClaudSkills desktop app (one click) or copy SKILL.md from the source repository to ~/.claude/skills/iso-13485-certification/SKILL.md and restart Claude Code. Both flows are detailed at claudskills.com/install/.

What does the Iso 13485 Certification skill do?

Is this skill free to install?

Yes. ClaudSkills is an open registry — every skill keeps its source repository's license, and manual install via copy is free. ClaudSkills Pro ($9/mo, $79/yr, or $149 one-time) adds one-click install via the desktop app and a multi-signal Quality Score.

When should I use the Iso 13485 Certification skill?

Use Iso 13485 Certification when your Claude Code task falls under the General category — specifically in the general misc area. Claude Code auto-discovers installed skills and invokes the right one based on the task description, so you can also ask Claude directly (e.g. "use Iso 13485 Certification" or describe the task and let Claude pick). Browse related skills at /category/general/.

What is a Claude Code skill and how does the Iso 13485 Certification skill fit in?

A Claude Code skill is a SKILL.md file that lives under ~/.claude/skills/<name>/ and tells the Claude Code CLI agent how to perform a specific task (instructions, prompts, allowed tools). Skills are auto-discovered at session start. Iso 13485 Certification is one of 67,000+ skills indexed in the open ClaudSkills catalog, classified under the General category. Learn more at /learn/what-is-a-claude-skill/.

Attribution & license

License: MIT 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/}
}

Embed this skill

Promote, attribute, or link this skill from your own README, blog post, or documentation. All three snippets are free to use — no sign-up, no API key. More distribution surfaces →

Badge

[![ClaudSkills](https://claudskills.com/badge/iso-13485-certification.svg)](https://claudskills.com/skills/iso-13485-certification/?utm_source=badge&utm_medium=readme&utm_campaign=skill_badge)

Security scan

Grade A · scanned 2026-07-06 — free static scan against the OWASP Agentic Skills Top 10.

No risk patterns were found in any of the ten OWASP-aligned categories. How grading works ›

✓ Prompt injection
✓ Data exfiltration
✓ Supply chain
✓ Reverse shell
✓ Credentials
✓ Execution
✓ Filesystem
✓ Persistence
✓ Obfuscation
✓ Network

Show this grade on your repo (click to copy):

[![Security: A](https://img.shields.io/badge/Security-A-2e7d32)](https://claudskills.com/skills/iso-13485-certification/#security)

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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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