regulatory-affairs

Turn any AI agent into a clinical pharmacologist and pharmacometrician. It reviews, reconciles, and prepares evidence. It never selects a dose, signs off, or submits.

MNC-style pharmaceutical pipeline asset assessment Agent Skill

MAUDEMetrics: Open-source no-code desktop app (macOS, Windows) and Docker service for automated extraction and standardization of FDA MAUDE medical device adverse event data via the openFDA API. Bypasses the 26,000-record limit and produces reproducible, analysis-ready datasets — no programming required.

Decision-centric AI governance framework for biopharma/biotech development. Ten-question independent study on FDA reconstructability, AI accountability, and schema-validated decision logs.

RAPath Global Hub - Medical Device Regulatory Reference in Plain English. Properly sourced.

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

LGD AI 治理与 A³ 法则知识库 · AI 友好公开源（治理方法论/证据门禁/记忆工程/自进化）

DSH 插件：扫描对外发布内容中的密钥/凭证/PII/内部路径泄漏，呼应防盗泄露铁律

LGD 九声矩阵与品牌生态知识库 · AI 友好公开源（九声大使/共生专家团/理论研究团）

UIBC-MEM: The Memory Migration Competition — agents compete via a single API call / MCP. Universal Infrastructure for Bounded-lifecycle Competition (XLGD).

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

A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.

SynomosAI skill - premise-and-config-audit - (c) 2026 SynomosAI - MIT

SynomosAI skill - medxpert-skill-panorama - (c) 2026 SynomosAI - MIT

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.

SynomosAI XCGS · AI 治理系统：A³ 法则 / AI 护照 / 可审计证据链 / Human-in-the-Loop。作者 赵兴华（Steven Zhao·China ｜ ORCID 0009-0001-0512-1237），版权 SynomosAI · CC BY 4.0，代码 MIT。

Medical device standards knowledge base (ISO 13485/14971, IEC 60601, MDR Annex VIII, GB 9706, etc.). Read-only MCP runtime for regulatory standards query across 27 knowledge hubs. Zero egress, zero cr

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

Анализ реестра медицинских изделий Казахстана (НЦЭЛС): сбор данных через недокументированный API, MySQL, SQL-аналитика, Power BI дашборд

SynomosAI skill - medxpert-l1-batch-study - (c) 2026 SynomosAI - MIT