ISO 13485 Certification (Claude Skill)

Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems.


Type	Claude Skill
Supplier	K-Dense Inc. (community OSS)
Availability	GA — part of the actively maintained K-Dense `scientific-agent-skills` collection
Pricing	Free / OSS (MIT)
Capabilities	Read/Write — Claude runs the skill’s Python locally (Bash), not as an MCP tool

How to install

Claude Code / Claude.ai — Skills CLI (recommended):
```
npx skills add K-Dense-AI/scientific-agent-skills
```
Installs the K-Dense collection; enable the iso-13485-certification skill when prompted. Works across Claude Code, Cursor, and Codex via the Agent Skills spec (requires Node ≥ 18).
Claude Code / Claude Desktop — manual clone:
```
git clone https://github.com/K-Dense-AI/scientific-agent-skills
cp -r scientific-agent-skills/skills/iso-13485-certification ~/.claude/skills/
```
Project-scoped alternative: copy into .claude/skills/ instead of ~/.claude/skills/. The skill declares its own Python dependencies in its SKILL.md; install them (the K-Dense skills generally use uv / pip) when prompted on first use.

What it does

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.

Primary use cases: 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.

Notes

Distributed as a SKILL.md (plus code examples) in the K-Dense collection — Claude executes it locally via Bash/Python rather than as an MCP server. Upstream license: MIT. The skill name to enable after install is iso-13485-certification.

Sources

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