iso-13485-certification
iso-13485-certification is a Privacy & regulatory compliance skill for AI agents, published by foryourhealth111-pixel in the Vibe-Skills repository on GitHub. Skillspace rates iso-13485-certification B (82/100) and it passed the safety scan; a judge model has also reviewed it.
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.
- Grade
- B
- Quality
- 82 / 100
- Safety
- Passed
- GitHub stars
- 2,381
Placed #6 of 6 in the judged category final for Privacy & regulatory compliance.
Our two independent classifiers differ on this skill's category, so treat the placement as provisional.
This rating describes the version of the repository we crawled; it may have changed since, so go by its current files.
Our review
- Architecture
- 91 / 100
- Maturity
- Packaged: licensed, with a version or references
- Security scan
- No issues found
- License
- Apache-2.0
- Adoption
- Adopted by 0 other repositories, in 3 collections
- Scope
- Portable: works in any project. General ISO 13485 QMS methodology for any manufacturer.
Judge review
Placed #6 of 6 in the judged category final for Privacy & regulatory compliance.
- Trigger
78 78 - Instructions
82 82 - Specificity
83 83 - Safety
62 62 - Disclosure
78 78 - Maintenance
72 72
Practical template- and script-driven ISO 13485 doc builder, but lacks the explicit certification-boundary and copyright discipline the category's best entry states up front.
Not checked yet
- No blind task eval yet
- Sibling files (scripts, references) not fetched; security scan covers SKILL.md only
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