non-clinical-checker

文档型决策支持工具，声称依据 TH-MED-001 域官方规则库，对医疗器械研发立项、临床/注册申报前的非临床研究属性做逻辑判定与合规校验，输出含结论、引用条款与风险点的 JSON IR。声明零依赖、无需脚本；证据与独立安全扫描状态均标注为 TBD。

zhaoxinghua09-cell

热度 61.25

最近更新 2026-10-17 07:31:52

分类：安全依赖：代码执行 / 读写文件 / 内部调用大模型应用场景：法律文档 / 研究

安装技能

复制下面的话术发给你的 Agent，它会通过 secure-skills 检索并安装该技能。

执行命令安装此 skill： npx secure-skills-cli add non-clinical-checker

Metadata

name: non-clinical-checker
title: Medical Device Non-clinical Research Checker
slug: non-clinical-checker
display_name: 医疗器械非临床研究判定器
display_name_en: Medical Device Non-clinical Research Checker
version: 1.0.1
category: medtech-reg
author: SynomosAI
license: MIT
allowed-tools: Read, Glob, Grep, Bash, Write, WebFetch
description: 医疗器械非临床研究判定器——基于官方规则源的零依赖决策支持工具，JSON IR 输出，覆盖 TH-MED-001 域（医疗器械全链路）。
description_zh: 医疗器械非临床研究判定器——基于官方规则源的零依赖决策支持工具，JSON IR 输出，覆盖 TH-MED-001 域（医疗器械全链路）。
description_en: Medical device non-clinical research determination tool: zero-dependency decision support with JSON IR output (domain TH-MED-001, full device chain).
tags: ["医疗器械","合规","判定器","TH-MED-001","non-clinical-checker","medtech-reg"]
classification: {"skillhub":["medtech-reg","medical-device","compliance"],"clawhub":["productivity","development","search"],"iso_25010":["Functional suitability"]}
read_when: ["研发立项初期依据 TH-MED-001 域规则判定研究阶段是否属非临床范畴","临床/注册申报前验证已产生非临床数据的合规性与有效性","审查内部设计方案是否存在违反官方规则的非临床实验安排"]
risk_tier: medium
risk_rationale: 调用 API/读写文件/本地执行，最小权限，密钥走 Secret；若实际涉对外代执行(push/发布/发送/上架)须人工复评，改 high 并走负责人批准。
platforms: ["windows","macos","linux"]
platform_compatibility: ["windows","macos","linux"]
ai_protocol: true
spec: usk/1.0
interface: {"type":"prompt","entry_point":"SKILL.md","runtime":"none","call_pattern":"prompt"}
output_schema: {"stdout":"structured JSON IR","exit_code":"rc=0 ok / rc=1 warning / rc=2 bad input"}
changelog: 1.0.1: Bilingual rewrite (EN-first) + read_when; risk_rationale ref neutralized; 1.0.0 initial

凡自治之物 · LGD 治理学 · 创造术家族｜评测协议：skill-quality-gate

English

Medical Device Non-clinical Research Checker

When to use

At R&D project initiation, use TH-MED-001 domain rules to quickly determine whether a research stage falls under non-clinical research.
Before clinical trial or registration submission, verify the compliance and validity of non-clinical data already produced.
When an R&D organization needs to review internal design plans for non-clinical arrangements that violate official rules.
Zero-dependency regulatory rule comparison for a specific device model, producing standardized determination recommendations.

How to use

Documentation-type tool; no scripts to run. The user describes device parameters and target standard numbers in natural language; the system retrieves and logically matches against the built-in official rule library. Results are structured as JSON IR for direct parsing.

Workflow

Provide the device model and the non-clinical research scope to evaluate.
The system silently loads TH-MED-001 rules and matches across conditions.
Logical determination: validate research-stage attributes and experiment conditions against official definitions.
Generate JSON IR with conclusion, cited clauses, and risk analysis.
Parse the result and confirm it meets the zero-dependency output format.
Revise the R&D plan or adjust inputs to close the compliance loop.

Evidence & safety

Evidence: TBD; Version: 1.0.1; Security: no independent scan (TBD).

中文

医疗器械非临床研究判定器

何时用

研发立项初期，依据 TH-MED-001 域规则快速判定研究阶段是否属于非临床研究范畴。
临床/注册申报前，辅助验证已产生非临床数据的合规性与有效性。
审查内部设计方案是否存在违反官方规则的非临床实验安排。
针对特定型号器械做零依赖法规规则比对，生成标准化判定建议。

用法

文档型工具，无需调用脚本或安装插件。用户以自然语言描述器械参数与目标标准号，系统基于内置官方规则库检索与逻辑匹配；结果以 JSON IR 结构化输出，可直接解析集成。

流程

提供型号与评估范围 → 系统加载 TH-MED-001 规则并匹配 → 按官方定义做合规校验 → 生成含结论/引用条款/风险点的 JSON IR → 解析确认格式 → 修正研发计划或调整输入闭环。

证据与安全声明

证据：TBD；版本：1.0.1；安全：未做独立安全扫描（TBD）。