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 Cleo-Labs-IA/skills_library --skill medical-device-compliancegit clone --depth 1 https://github.com/Cleo-Labs-IA/skills_libraryWrote 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/cleo-labs-ia/skills_library/medical-device-compliance)<a href="https://agentmods.dev/skills/cleo-labs-ia/skills_library/medical-device-compliance"><img src="https://agentmods.dev/badge/skills/cleo-labs-ia/skills_library/medical-device-compliance/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/cleo-labs-ia/skills_library/medical-device-compliance"><img src="https://agentmods.dev/badge/skills/cleo-labs-ia/skills_library/medical-device-compliance.svg" alt="Reviewed on agentmods" width="80" height="20"></a>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 | $0.00077 | $0.03620 |
| Opus 5 | $0.00039 | $0.01810 |
| Sonnet 5 | $0.00015 | $0.00724 |
| Haiku 4.5 | $0.00008 | $0.00362 |
Grade A, and why
medical-device-compliance 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 — 188 lines — stays where its author put it; the contents beside it link to each section on GitHub.
Medical Device Compliance
Full regulatory workflow for medical devices, IVDs, and software as a medical device (SaMD). EU MDR/IVDR, FDA, UKCA, classification, clinical evaluation, post-market.
Decision Flow
digraph {
rankdir=TB; node [shape=box style=rounded fontsize=10];
qualify [label="1. Qualify as medical device\n(MDR Art. 2, FDA 201(h))"];
classify [label="2. Classify:\nEU I/IIa/IIb/III, FDA I/II/III"];
pathway [label="3. Choose pathway:\nself-cert / NB / 510(k) / PMA / De Novo"];
qms [label="4. QMS ISO 13485\n+ Risk mgmt ISO 14971"];
clinical [label="5. Clinical evaluation\n(MEDDEV 2.7/1 rev 4)"];
tech [label="6. Technical Documentation\n(MDR Annex II/III)"];
audit [label="7. NB audit / 510(k) review\n/ PMA submission"];
udi [label="8. UDI assignment\n+ EUDAMED registration"];
pms [label="9. Post-Market Surveillance\nplan + PMCF"];
sell [label="10. Place on market"];
qualify -> classify -> pathway -> qms -> clinical -> tech -> audit -> udi -> pms -> sell;
}
EU -- MDR 2017/745
| Requirement | Detail |
|---|---|
| Legal basis | Regulation (EU) 2017/745 (MDR) -- fully applicable since 26 May 2021. Transitional provisions to 26 Dec 2027 (Class III/IIb implantables) and 31 Dec 2028 (other Class IIa/IIb/Im/Is/Ir) per Reg 2023/607 |
| Classification | Annex VIII rules 1-22. Class I (low risk), IIa (medium), IIb (medium-high), III (high risk). Software per Rule 11 (most clinical SaMD = Class IIa minimum) |
| Pathway | Class I non-sterile/non-measuring: self-declaration. Class Is/Im/Ir: Notified Body for sterility/measurement/reusable aspect only. Class IIa+: full NB conformity assessment (Annex IX or X) |
| Notified Body | ~50 NB designated under MDR (vs 80+ under old MDD). 18-24 month wait times. List: NANDO database |
| Technical Documentation | MDR Annex II + III: device description, design info, GSPR checklist (Annex I), risk management ISO 14971, verification/validation, clinical evaluation, labeling, PMS plan |
| Clinical evaluation | MDR Article 61 + Annex XIV. MEDDEV 2.7/1 rev 4 still referenced. Equivalence routes restricted under MDR. Implants + Class III need own clinical investigations |
| QMS | ISO 13485:2016 required. Annex IX requires NB to audit QMS |
| UDI | Basic UDI-DI + UDI-DI (production identifier). Carrier: GS1, HIBCC, ICCBBA. Direct marking on reusable devices |
| EUDAMED | EU database. Modules: Actor registration (live), UDI/Device (live but voluntary), NB/Certificate (live), Clinical Investigation (partial), Vigilance (live), PMS (pending). Mandatory use phased |
| Authorized Representative | Non-EU manufacturers MUST appoint EU AR (MDR Article 11) |
| Timeline | Class I: 1-3 months. Class IIa: 8-14 months (incl. NB wait). Class IIb: 12-18 months. Class III: 18-36 months |
| Cost | Class I: EUR 5,000-30,000. Class IIa: EUR 50,000-200,000 + NB fees EUR 30,000-100,000/year. Class III: EUR 500,000-2,000,000+ |
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 · 188 lines · 77 tokens per session scan A 20164cb8278a
medical-device-compliance is a skill published in the GitHub repository Cleo-Labs-IA/skills_library (1 stars, last pushed 3mo ago), licensed MIT. It adds 77 tokens to every session and 3,620 once invoked, about $0.0004 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 2026-08-31.
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