Skill UI

This guide outlines the strict multi-environment setup for the OpenEvidence clinical AI system, crucial for maintaining HIPAA compliance. It details how to configure and validate separate environments (Development, Staging, Production) to manage different data classifications—synthetic, de-identified, and full PHI. The process emphasizes environment validation checks, BAA adherence, and robust audit logging to prevent regulatory violations and PHI exposure.

Provides comprehensive observability for OpenEvidence, a system delivering critical clinical evidence queries. It monitors key metrics such as query response latency (p95), evidence freshness, citation accuracy, and compliance audit logs (HIPAA). Essential for ensuring timely, accurate, and regulatory-compliant patient care information retrieval.

A comprehensive guide for auditing and ensuring regulatory compliance (SOC2, GDPR, HIPAA) when integrating Large Language Models (LLMs) via OpenRouter. It covers best practices for data handling, access control, PII redaction, implementing robust audit trails, and configuring provider routing to maintain data sovereignty and meet strict industry standards.

This comprehensive guide provides expertise in conducting ISO 13485 internal audits for medical device Quality Management Systems (QMS). It covers the full audit lifecycle, including risk-based planning, systematic evidence collection, classifying nonconformities (Major/Minor), and managing CAPA verification to ensure regulatory compliance and continuous improvement.

This guide defines the role and responsibilities of a Senior Quality Manager Responsible Person (QMR) for highly regulated MedTech and HealthTech environments. It covers essential functions under ISO 13485, including leading management reviews, establishing quality objectives, monitoring performance KPIs, and maintaining strict regulatory compliance oversight. Use this resource when developing a Quality Management System (QMS) or managing regulatory accountability.

Implements and maintains ISO 13485 QMS for medical device organizations, covering gap analysis, documentation control, internal audits, supplier qualification, and CAPA tracking to keep regulatory programs audit-ready.

Provides senior regulatory affairs guidance for HealthTech and MedTech firms, driving FDA 510(k)/De Novo/PMA submissions, CE marking, and multi-market access strategies while maintaining intelligence on evolving regulations.

A comprehensive guide for implementing ISO 14971:2019 risk management across the entire medical device lifecycle. Covers planning, hazard identification, risk analysis (FMEA, FTA), risk evaluation, risk control, and post-market surveillance. Essential for achieving regulatory compliance in medical device development.

This skill provides a comprehensive toolkit for calculating essential portfolio risk metrics. It includes Value at Risk (VaR), Conditional VaR (CVaR), Sharpe Ratio, Sortino Ratio, and drawdown analysis. It is crucial for measuring overall portfolio risk, implementing risk limits, building sophisticated risk dashboards, and ensuring compliance for regulatory reporting in finance.

This expert simulates a compliance expert, specializing in regulatory requirements for software systems, including GDPR, HIPAA, SOC2, and PCI-DSS. It performs comprehensive audits, identifies compliance gaps, and generates actionable implementation plans, technical controls, and policy templates to ensure adherence to industry standards.

This guide provides comprehensive instructions for setting up and managing Sentry's enterprise-grade Role-Based Access Control (RBAC). It covers establishing the Organization-Team-Project hierarchy, integrating Single Sign-On (SSO) via SAML2, and automating user provisioning with SCIM. Use this when setting up large-scale organizations, enforcing granular team permissions, centralizing identity management, or ensuring regulatory compliance and audit logging.

This skill acts as a specialized domain intelligence strategist, capable of analyzing specific industry niches (e.g., Fintech, HealthTech). It goes beyond general functionality to inject crucial domain-specific knowledge, mandatory regulatory compliance (like HIPAA or GDPR), and industry-leading UX/UI patterns. Essential for ensuring the product is optimized for its vertical market.