Skip to content

From the author

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.

Install

npx skills add foryourhealth111-pixel/Vibe-Skills --skill iso-13485-certification -a claude-code

Installs to .claude/skills/iso-13485-certification/ · Each command fetches the skill straight from GitHub with the open skills CLI.

Download .zip

Byte-identical to the scanned commit, with the repository’s licence and a SOURCE.txt.

Want your agent to suggest skills while you type? See how to use skills from your IDE.

Safety checks on SKILL.md

  • Ships scripts we have not reviewedLow

Why 84

Security85
Provenance83
Maintenance100
Licence100
Adoption57

aiqbench computes the trust score from public signals. It is not a security audit, so read a skill before you install it.

Similar skills

From the same category, best-trusted first. This skill is not indexed for matching yet, so these are its neighbours by category.

Ratings & reviews

—

no reviews

Tried this skill? Rate it to help others. Sign in

    Discussion

    Join the discussion. Sign in