Skill UI

A comprehensive guide for Corrective and Preventive Action (CAPA) management within Quality Management Systems (QMS), specifically tailored for medical devices. It covers the entire investigation lifecycle, including root cause analysis (RCA) using methodologies like 5-Why and Fishbone diagrams, developing robust corrective actions, and verifying effectiveness to ensure continuous compliance and quality improvement.

This skill serves as a comprehensive health assistant, designed to analyze complex medical information, track symptoms over time, and provide personalized wellness guidance. It is useful for users seeking structured health monitoring and preliminary insights into their condition, but it must not replace professional medical diagnosis or advice.

Comprehensive guidance for medical device manufacturers navigating complex FDA regulatory requirements. Covers device classification, submission pathways (510(k), PMA, De Novo), Quality Management System Regulation (QMSR/ISO 13485), HIPAA compliance, and cybersecurity best practices. Use this when determining the correct regulatory route for a new or modified device.

A comprehensive guide for achieving compliance with the EU MDR 2017/745. It covers crucial aspects including medical device classification (Annex VIII), developing technical documentation (Annex II/III), planning clinical evaluation (CER), and establishing post-market surveillance (PMS/PSUR) systems. Ideal for regulatory specialists preparing for Notified Body audits or needing to gap-check technical files.

Automates the Continuous Integration and Continuous Deployment (CI/CD) process for OpenEvidence clinical decision support integrations. This setup ensures that unit tests (using mocked evidence queries and citations) and live API connectivity tests are run automatically on every pull request and merge to main. It validates critical functions like query formatting, evidence parsing, citation extraction, and response quality scoring, maintaining high reliability for medical AI applications.

A comprehensive workflow designed for clinical professionals to search, retrieve, and synthesize medical evidence. It allows users to query clinical literature with specialized filters (e.g., specialty, evidence level), check potential drug interactions against patient profiles, and look up the latest specialty guidelines from major health organizations (like ACC/AHA, NICE). The output provides structured citations, confidence scores, and evidence grading to support informed clinical decision-making.

A comprehensive workflow for systematically reviewing medical evidence. It allows users to search databases for clinical studies, build curated citation collections, grade evidence using established frameworks like GRADE, and generate professionally formatted, structured reports in academic citation styles (e.g., AMA). Ideal for conducting literature reviews and supporting clinical research. This tool helps transform raw medical data into actionable, structured knowledge.

This skill provides a complete guide to deploying a containerized OpenEvidence clinical evidence integration service using Docker. It establishes a HIPAA-conscious production environment, enabling secure connections to the OpenEvidence API. Users can query clinical evidence, retrieve summarized medical literature, and validate treatment recommendations, all while maintaining audit logging and data-at-rest encryption compliance. Includes setup for health checks and rolling updates.

This system implements Role-Based Access Control (RBAC) for OpenEvidence, an AI-powered clinical decision support platform. It strictly manages access to sensitive data, including PHI-adjacent datasets and medical literature, ensuring compliance with regulations like HIPAA. The system defines distinct roles—Admin, Clinician, Researcher, Student, and Auditor—with granular permissions for querying, data export, and institutional configuration, maintaining a secure and auditable data environment.

This module provides minimal working examples for the OpenEvidence API, designed for clinical intelligence applications. Users can perform complex clinical queries to get treatment recommendations, check potential drug interactions based on patient context, and search for authoritative medical guidelines from major health organizations (e.g., ACC/AHA). Ideal for developing evidence-based healthcare decision support systems.

This guide provides comprehensive steps to install and authenticate the OpenEvidence SDK/API. It covers setting up environment variables, installing required packages (supporting both Node.js and Python), and verifying the connection using sample code. This is essential for developers integrating OpenEvidence's medical AI capabilities for clinical decision support and evidence-based queries into a new application.

This SDK provides comprehensive, production-ready patterns for interacting with the OpenEvidence clinical evidence API. It enables developers to efficiently query medical literature, retrieve clinical guidelines, and generate evidence-based recommendations. Key features include a singleton client for consistent authentication, robust error wrappers (handling retries, invalid keys), and structured data models designed to ensure audit compliance and detailed citation provenance in complex healthcare applications.