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iso-13485-certification

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.

66

Quality

81%

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SecuritybySnyk

Low

Low-risk findings worth noting

SKILL.md
Quality
Evals
Security

Low

Low-risk findings.

1 low severity finding. Worth noting, but not necessarily harmful.

Low

W011: Third-party content exposure detected (indirect prompt injection risk).

What this means

The skill exposes the agent to untrusted, user-generated content from public third-party sources, creating a risk of indirect prompt injection. This includes browsing arbitrary URLs, reading social media posts or forum comments, and analyzing content from unknown websites.

Why it was flagged

The required runtime workflow ingests user-provided existing QMS documents via a user-supplied directory (including .txt/.md/.doc/.docx/.pdf) for gap analysis and uses their content to review results and generate outputs, creating indirect prompt-injection exposure from outsider-authored text.

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Repository
wu-yc/LabClaw
Audited
Security analysis
Snyk

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