nmpa

神奇的蜘蛛🕷，一个几乎适用于所有web端站点的采集方案

SynomosAI / MedXpert 技能库 GitHub 镜像 · 31 个已发布 skill · 按六大使业务线组织 · 供 SkillsMP 自动发现

Medical device compliance tools. Self-assessment checklists for MDR / IVDR / SaMD / cybersecurity / post-market surveillance. Read-only, zero egress, audit-traceable.

Medical device testing coordination. Read-only tool for querying accredited testing labs, test method standards (IEC/ISO/GB), sample requirements and testing timelines across NMPA/FDA/MDR.

Convert sas code to txt format before submit to regulatory agency

Medical device regulatory document translator. Read-only MCP tools for terminology lookup across NMPA/FDA/MDR/Japan PMDA — NOT a general translator. Audit-traceable, conservative translation stance.

AWS Agents for Humans (Professional track): Strands Agents SDK multi-profile agent for medtech regulatory monitoring, submission readiness, and clinic compliance.

MedXpert 全球医械法规连接器 (reg-connector) — read-only MCP server, NMPA/FDA/MDR/PMDA knowledge hubs (27 pivots), 4 tools, zero egress. Install-by-consent (AI may request, human approves).

Medical device registration operational toolkit. Read-only MCP tools for querying NMPA/FDA/MDR submission paths, fee schedules, document checklists, and procedural timelines. Audit-traceable.

Agent Skills in two lines: SynomosAI (general AI: local LLM, KB tooling, brand assets) & MedXpert (medical-device regulatory: NMPA/FDA/MDR/PMDA). Works with Claude, Codex, Cursor, Gemini CLI, Coze and 30+ clients.

NMPA eCTD submission dossier assembler with per-claim evidence chain — messy PDF/Word/Excel sources → compliant package (index.xml + M1–M5), every value traceable to its source cell. 脏源文件→合规申报包，逐字段可溯源。

医疗器械分类与注册路径分析自动化工具：规则引擎 + CMDE 临床评价路径 + 豁免目录校验（NMPA/CMDE 公开数据）

MedXpert 医疗器械合规 AI 技能库 · 目录与安装指引

Open dataset of multiple myeloma clinical trials registered in China, curated from NMPA/CDE filings with normalized trial centers, populations and registry status. CC BY 4.0.