non-clinical-checker

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）。

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

1. At R&D project initiation, use TH-MED-001 domain rules to quickly determine whether a research stage falls under non-clinical research.
2. Before clinical trial or registration submission, verify the compliance and validity of non-clinical data already produced.
3. When an R&D organization needs to review internal design plans for non-clinical arrangements that violate official rules.
4. 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

1. Provide the device model and the non-clinical research scope to evaluate.
2. The system silently loads TH-MED-001 rules and matches across conditions.
3. Logical determination: validate research-stage attributes and experiment conditions against official definitions.
4. Generate JSON IR with conclusion, cited clauses, and risk analysis.
5. Parse the result and confirm it meets the zero-dependency output format.
6. 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

1. 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。
2. 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。
3. 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。
4. 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）。