Medical device registration assistant (read-only MCP). Operates as a tool agent — does NOT provide medical advice or clinical judgment. For documentation query, regulatory path comparison, submission
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).
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 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.
MedXpert 医疗器械合规 AI 技能库 · 目录与安装指引
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.
MedXpert 医械注册实务知识库 · 公开同源源 (SSOT)
SynomosAI Traceability Audit v1.0 - 可溯源/可举证/可审计的 AI 系统方法论与参考实现（三锚核验/证据链审计/真实参照法/注册方法论）。署名 SynomosAI · 安全服务大使 Phylax（诺卫）。
临床评价（CER）路径规划与 PMCF 计划生成：同品种比对（EU MDR Annex XIV + MEDDEV 2.7.1 rev.4）、临床试验路径、NMPA 临床评价指导原则路径、FDA 510(k) 实质等效；PMCF 计划模板（终点/人群/随访/统计）与 PSUR/CER 更新触发条件。
Project developed for the Real-Time Embedded Systems course
Multimodal camera-based assessment of therapeutic exercise in breast-cancer-related lymphedema rehabilitation — kinematics, relative EMG, pain mapping, blinded human + AI evaluation (JBHI revision artifact)
Explainable, retrieval-augmented LLM for clinical decision support. Classifies MIMIC-IV ED records into 10 body-system disease groups (MedGemma-4B + QLoRA, PubMedBERT+FAISS, Qwen2.5-14B explainer) with auditable, clinician-validated explanations. Macro-F1 0.7253 on a single 15GB GPU.
内容发布全流程（设计→落地→检查→验证→发布→沉淀）
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