Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance
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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.
This skill integrates with the following processes:
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
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Security audit, hardening, threat modeling (STRIDE/PASTA), Red/Blue Team, OWASP checks, code review, incident response, and infrastructure security for any project.
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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
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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
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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).
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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.
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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
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