pms-vigilance-intake

医疗器械不良事件报告路径判定器——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-002 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 Vigilance Reporting Pathway Intake

When to use

1. When newly submitted adverse-event data arrives and its statutory reporting pathway must be determined.
2. For triaging complex events involving multi-department jurisdiction, classifying them against the official rule library.
3. When an automated flow needs JSON-IR-standard decisions parseable by downstream steps.

How to use

Pure documentation tool; no local scripts. Pass structured adverse-event elements or a full report summary as input; the interface returns JSON IR with the recommended pathway and rationale.

Workflow

1. Confirm the adverse-event data has been basic-validated and formatted.
2. Wrap the structured text as input into the skill node.
3. Trigger execution; the backend matches TH-MED-002 regulatory rules.
4. Inspect the returned JSON IR for the recommended pathway code and clauses.
5. Close the business loop or route for manual review.

Evidence & safety

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

中文

医疗器械不良事件报告路径判定器

何时用

1. 收到新提交的不良事件数据，需自动判定其法定报告路径。
2. 涉及多部门管辖的复杂事件初筛，需按官方规则库合规分类。
3. 自动化流程需生成符合 JSON IR 标准、可被后续步骤直接解析的决策建议。

用法

纯文档型工具，无需本地执行脚本。以结构化不良事件要素列表或完整报告摘要为输入，返回含推荐路径与判定依据的 JSON IR。

流程

完成数据基础校验与格式化 → 封装为输入参数 → 触发执行并匹配 TH-MED-002 规则库 → 查看 JSON IR 中推荐路径代码与条款 → 闭环或转人工复核。

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）。