| name | iso-13485-certification |
| description | 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). |
| source_skill_id | k-dense-ai-scientific-agent-skills-scientific-skills-iso-13485-certification-skill-md |
| category | Science, research & data analysis |
| source_mirror | ../../../../../skills/by-category/science-research-data-analysis/latest-release-community/iso-13485-certification/SKILL.md |
| benchmark_status | artifact_gated |
iso-13485-certification
Use this skill when the task matches the description above or the source path clearly applies. Start with this concise entrypoint; open ../../../../../skills/by-category/science-research-data-analysis/latest-release-community/iso-13485-certification/SKILL.md only when implementation details, commands, assets, or references are needed.
Workflow
- Confirm the task matches this skill's scope.
- Read the local source mirror if more detail is required.
- Follow repository-level
AGENTS.md; use one AI session only.
- Keep claims tied to files, commands, citations, or benchmark artifacts.
Verification
- Source mirror:
../../../../../skills/by-category/science-research-data-analysis/latest-release-community/iso-13485-certification/SKILL.md
- Source commit:
eb20fb0dcb0b1dadaa3db2737188f0755bbc4770
- Static benchmark results: see
docs/benchmark-results.md
- Runtime artifacts recorded by this entrypoint:
0
- Assigned scenarios:
skill-proof-k-dense-ai-scientific-agent-skills-scientific-skills-iso-13485-certification-skill-md, science-research-and-data-analysis-cellxgene-census, science-research-and-data-analysis-chembl, science-research-and-data-analysis-ome-ngff-samples
Do not claim this skill passed a runtime benchmark until a validated artifact exists.
