Getting it into your agent
One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.
npx skills add AlterLab-IEU/AlterLab-Academic-Skills --skill alterlab-iso13485git clone --depth 1 https://github.com/AlterLab-IEU/AlterLab-Academic-SkillsWrote this? Show the measurements
A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.
[](https://agentmods.dev/skills/alterlab-ieu/alterlab-academic-skills/alterlab-iso13485)<a href="https://agentmods.dev/skills/alterlab-ieu/alterlab-academic-skills/alterlab-iso13485"><img src="https://agentmods.dev/badge/skills/alterlab-ieu/alterlab-academic-skills/alterlab-iso13485/github.svg" alt="Measured on agentmods" height="20"></a>Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.
<a href="https://agentmods.dev/skills/alterlab-ieu/alterlab-academic-skills/alterlab-iso13485"><img src="https://agentmods.dev/badge/skills/alterlab-ieu/alterlab-academic-skills/alterlab-iso13485.svg" alt="Reviewed on agentmods" width="80" height="20"></a>- NVIDIA SkillSpector pass
What it costs to keep this loaded
Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.
| Model | Per session | Once invoked |
|---|---|---|
| Fable 5.1 | $0.00115 | $0.01704 |
| Opus 5 | $0.00057 | $0.00852 |
| Sonnet 5 | $0.00023 | $0.00341 |
| Haiku 4.5 | $0.00012 | $0.00170 |
Grade A, and why
alterlab-iso13485 scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 12d ago.
A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.
Nothing flagged
None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.
How it starts
The opening of the file, as written. The whole thing — 150 lines — stays where its author put it; the contents beside it link to each section on GitHub.
ISO 13485 Certification Documentation Assistant
Overview
This skill helps medical device manufacturers prepare comprehensive documentation for ISO 13485:2016 certification. It provides tools, templates, references, and guidance to create, review, and gap-analyze all required Quality Management System (QMS) documentation.
What this skill provides:
- Gap analysis of existing documentation
- Templates for all mandatory documents
- Comprehensive requirements guidance
- Step-by-step documentation creation
- Identification of missing documentation
- Compliance checklists
When to use this skill:
- Starting ISO 13485 certification process
- Conducting gap analysis against ISO 13485
- Creating or updating QMS documentation
- Preparing for certification audit
- Transitioning from FDA QSR to QMSR
- Harmonizing with EU MDR requirements
Core Workflow
1. Assess Current State (Gap Analysis)
When to start here: User has existing documentation and needs to identify gaps
Process:
-
Collect existing documentation:
- Ask user to provide directory of current QMS documents
- Documents can be in any format (.txt, .md, .doc, .docx, .pdf)
- Include any procedures, manuals, work instructions, forms
-
Run gap analysis script:
python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json -
Review results:
- Identify which required procedures are present vs. missing. The script checks the 26 always-applicable documented procedures (it omits the conditional "when applicable" ones — design, installation, servicing, sterilization, etc. — to avoid false-negative gaps); the full set is "31" by convention. See
references/quick-reference.mdfor the full list and counting note. - Identify missing key documents (Quality Manual, MDF, etc.)
- Calculate compliance percentage (reported against the 26 procedures the script tracks)
- Prioritize missing documentation, including any conditional procedures that apply to this manufacturer
- Identify which required procedures are present vs. missing. The script checks the 26 always-applicable documented procedures (it omits the conditional "when applicable" ones — design, installation, servicing, sterilization, etc. — to avoid false-negative gaps); the full set is "31" by convention. See
What ships with it
13 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.
- assets/templates/procedures/CAPA-procedure-template.md 15 KB
- assets/templates/procedures/document-control-procedure-template.md 18 KB
- assets/templates/quality-manual-template.md 20 KB
- evals/evals.json 5.2 KB
- references/best-practices.md 2.3 KB
- references/common-scenarios.md 4.8 KB
- references/document-creation-guide.md 7.0 KB
- references/gap-analysis-checklist.md 27 KB
- references/iso-13485-requirements.md 25 KB
- references/mandatory-documents.md 21 KB
- references/quality-manual-guide.md 26 KB
- references/quick-reference.md 2.5 KB
- scripts/gap_analyzer.py 16 KB runs code
What this file has done since we first saw it
Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.
- 12d ago First seen · 150 lines · 115 tokens per session scan A f2fd4f837085
alterlab-iso13485 is a skill published in the GitHub repository AlterLab-IEU/AlterLab-Academic-Skills (66 stars, last pushed 7d ago), licensed MIT. It adds 115 tokens to every session and 1,704 once invoked, about $0.0006 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-08-30.
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