007
免费Security audit, hardening, threat modeling (STRIDE/PASTA), Red/Blue Team, OWASP checks, code review, incident response, and infrastructure security for any project.
中文简介正在准备中。当前显示原文说明。
aibot88/sec_skill_store62026年5月27日 更新
免费在 GitHub 公开
adverse-event-reporter
Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance
中文简介正在准备中。当前显示原文说明。
查看安装方法包含的文件（2）
- SKILL.md2.4 KB
- source.json616 B
SKILL.md（原文）
安装前可以查看交给 AI 代理的指令内容。
Adverse Event Reporter Skill
Purpose
The Adverse Event Reporter Skill supports adverse event monitoring and regulatory reporting for medical devices, ensuring compliance with FDA MDR requirements and EU vigilance obligations.
Capabilities
- MDR reportability assessment
- FDA Form 3500A population assistance
- MEDWATCH submission guidance
- EU vigilance reporting templates
- Trend analysis and signal detection
- PSUR data compilation
- Field safety corrective action templates
- Complaint coding (MedDRA)
- Risk assessment updates
- Corrective action tracking
- Regulatory notification timelines
Usage Guidelines
When to Use
- Assessing adverse event reportability
- Preparing regulatory reports
- Conducting trend analyses
- Managing field actions
Prerequisites
- Complaint information received
- Investigation completed
- Device information available
- Regulatory requirements identified
Best Practices
- Assess reportability promptly
- Document decision rationale
- Track reporting timelines
- Integrate with risk management
Process Integration
This skill integrates with the following processes:
- Post-Market Surveillance System Implementation
- Clinical Evaluation Report Development
- Medical Device Risk Management (ISO 14971)
- EU MDR Technical Documentation
Dependencies
- FDA MAUDE database
- EUDAMED system
- MedDRA coding dictionary
- Complaint management systems
- Risk management databases
Configuration
adverse-event-reporter:
reporting-systems:
- FDA-MDR
- EU-vigilance
- Health-Canada
- TGA
report-types:
- death
- serious-injury
- malfunction
- field-safety-corrective-action
timelines:
- 30-day
- 5-day
- annual
Output Artifacts
- Reportability assessments
- FDA Form 3500A drafts
- EU vigilance reports
- Trend analysis reports
- PSUR contributions
- FSCA notifications
- Risk management updates
- Corrective action plans
Quality Criteria
- Reportability assessed per regulations
- Reports submitted within timelines
- MedDRA coding accurate
- Trend analysis comprehensive
- Risk management updated
- Documentation audit-ready
评价
还没有评价。欢迎分享你的使用感受。
评论
无需登录即可发表。欢迎分享使用感受、提问，或说明在哪些环境下无法运行。
还没有评论。来写第一条吧。
同一仓库的技能
Guides the creation of agile user stories and Gherkin feature files. Use when the user wants to create a user story, write acceptance criteria, define Gherkin scenarios, or author BDD feature files. This should trigger for requests such as Create a user story; Write a user story; I need to write a user story. Part of cursor-rules-java project
中文简介正在准备中。当前显示原文说明。
aibot88/sec_skill_store62026年5月27日 更新
Facilitates conversational discovery to create Architectural Decision Records (ADRs) for non-functional requirements using the ISO/IEC 25010:2023 quality model. Use when the user wants to document quality attributes, NFR decisions, security/performance/scalability architecture, or design systems with measurable quality criteria. This should trigger for requests such as Create ADR for Non-functional requirements; Document Non-functional requirements; Capture Non-functional requirements; Generate Non-functional requirements in an ADR. Part of cursor-rules-java project
中文简介正在准备中。当前显示原文说明。
aibot88/sec_skill_store62026年5月27日 更新
Run a health check on an existing project: dependency audit, security scan, test runner detection, CI/CD evaluation, and missing configuration analysis. Maps the three execution gates (pre/in/post) from /10x-bootstrapper to an assessment framework for existing codebases. Reads optional context/foundation/stack-assessment.md from /10x-stack-assess to focus checks on identified gaps. Writes context/foundation/health-check.md with findings, prioritized fixes, and an agent-readiness verdict. Use when the user has an existing project and wants to verify its health before working with an agent. Trigger phrases: "health check", "check my project", "audit my project", "is my project healthy", "sprawdź projekt", "audyt projektu", "health-check", "project health". Use AFTER /10x-stack-assess (brownfield chain), BEFORE agent onboarding (m1-l4).
中文简介正在准备中。当前显示原文说明。
aibot88/sec_skill_store62026年5月27日 更新
10x-team
免费You MUST use this when building projects end-to-end. Orchestrates all 12 team roles — automatically switches between CTO, architect, PM, engineers, SRE, security, DBA, QA, and EM based on the current phase of work. Starts with brainstorming before any implementation.
中文简介正在准备中。当前显示原文说明。
aibot88/sec_skill_store62026年5月27日 更新
Use when you need to add or configure Maven plugins in your pom.xml — including quality tools (enforcer, surefire, failsafe, jacoco, pitest, spotbugs, pmd), security scanning (OWASP), code formatting (Spotless), version management, container image build (Jib), build information tracking, and benchmarking (JMH) — through a consultative, modular step-by-step approach that only adds what you actually need. This should trigger for requests such as Add Maven plugins in pom.xml; Improve Maven plugins in pom.xml. Part of cursor-rules-java project
中文简介正在准备中。当前显示原文说明。
aibot88/sec_skill_store62026年5月27日 更新