Plugins

2 plugins

@alirezarezvani

14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, CAPA management, risk management, clinical evaluation, SOC 2 compliance.

10 skills · plugin

@alirezarezvani

Compliance OS — meta-orchestrator for multi-framework compliance programs spanning 9 frameworks (ISO 27001, ISO 13485, ISO 42001, ISO 14971, EU AI Act, MDR 745, GDPR, SOC 2, FDA QSR). Framework selector, cross-framework control mapper, audit simulator, and consolidated evidence-pool generator (stdlib Python), plus 3 cs-* compliance agents and 3 /cs:* readiness commands.

9 skills · plugin

Results for “fd”

5 skills

Drafts FDA product recall plans compliant with 21 CFR Part 7, covering Recall Committee governance, health hazard evaluation, recall classification, notification protocols, effectiveness checks, product disposition, and termination procedures. Use when developing recall SOPs, updating recall procedures, drafting recall readiness plans, or preparing FDA-regulated product recall documentation.

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Routes compliance requests to the appropriate regulatory and quality-management skill among 15 bundled options, covering ISO 13485, EU MDR, FDA submissions, ISO 14971, CAPA, document control, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2, and auditing.

Prüft Frist, Form, Zuständigkeit, Rechtsweg und Sofortmaßnahmen für eine Meldung nach Art. 33 DSGVO an die BfDI und liefert eine Fristen- und Risikoampel mit Sofortschritten.

brycewang-stanford

foreign-cf-study

根据研究者提供的**研究计划书（Research Proposal）**执行基于**外国（美国/欧盟/英国/日本/跨国）制度环境**的公司金融类实证研究全流程。**启动后第一件事：根据计划书的主题、识别策略、贡献边际与样本范围，从外国 CF 顶刊池（AER/QJE/JPE/JF/JFE/RFS/JFQA/JAR/JAE/MS/JCF/JBF 等 25+ 期刊）中推荐 5 本最匹配的目标期刊（[J1]–[J5]），等待研究者明确选定一本；该期刊决定 main.tex 的 bibliographystyle、Section 骨架、Introduction 风格与表注规范**。然后用 Python 完成数据清洗、描述性统计、基准回归、内生性检验（IV/2SLS、DML）、平行趋势、异质性、机制、稳健性检验与图表绘制。LaTeX 表格和图像严格遵循 template/ 示例格式，研究逻辑与排版严格遵循 rule/ 下的《通用实证研究逻辑与规范总结》与《回归表写作规范总结》。数据集与政策集从 asset/ 中按计划书中的关键词检索（WRDS / NBER/Fed releases / FRED / 全球宏观库）。**当计划书预期的实证结果无法实现时（系数不显著、平行趋势不通过、IV 弱工具、机制不成立等），skill 自动切换备选方案直至完成研究项目**。最终交付物：Python 代码 + LaTeX 表格 + 图像（.pdf/.png）。触发条件：研究者提交研究计划书（含 X→Y 假设、识别策略、样本、政策冲击等）。

Drafts SEC Form 8-K current reports with item-accurate narratives, exhibit indexing, and EDGAR-ready formatting. Use when a public company must disclose a reportable event (material agreement, acquisition, personnel change, Reg FD disclosure) or file a current report within four business days. Trigger on "Form 8-K", "current report", "8-K filing", "EDGAR", "Item 1.01", "Item 2.01", "Item 5.02", "Reg FD".