Skill UI

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.

This comprehensive guide defines the secure data lifecycle management for OpenEvidence, an AI-powered platform for clinical evidence synthesis. It outlines data classification (e.g., clinical queries, patient responses), strict adherence to global regulations (HIPAA, GDPR, FDA), and technical requirements for handling Protected Health Information (PHI). Key processes include PHI de-identification, data validation, secure API integration, and compliant data export, ensuring the system maintains the highest level of patient privacy and regulatory compliance.

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.

Provide REST API access to ClinPGx, the successor to PharmGKB, for querying gene-drug interactions, CPIC/DPWG/FDA guidelines, allele functions, and evidence that supports precision dosing and pharmacogenomics-driven clinical decisions.

Provides Python access to openFDA endpoints for drugs, devices, foods, veterinary products, and substances, enabling regulatory analysis, safety monitoring, recalls tracking, and pharmacovigilance research.

This specialized skill acts as an expert AI auditor for Food Safety Modernization Act (FSMA) compliance. It is designed to review critical records, including HACCP plans, Preventive Controls, and Supply Chain documentation for food processing facilities. Use it to simulate FDA inspections, identify compliance gaps (such as missing CCPs or inadequate corrective actions), and receive actionable guidance to ensure the highest standards of food safety.

This specialized AI acts as an auditor for Medical Devices (SaMD) compliance. It reviews critical documentation like Design History Files (DHF) and technical files against major global regulations, including 21 CFR Part 820, IEC 62304, and ISO 13485. It identifies compliance gaps, cites specific regulations, and provides actionable remediation steps to prepare for regulatory audits.

This router bundles 15 specialized compliance skills crucial for HealthTech and MedTech organizations. It provides structured guidance across major global regulations, including ISO 13485 QMS, EU MDR, FDA submissions, GDPR, and the EU AI Act. Use this when a compliance request is complex and needs to be accurately directed to a specific technical skill area (e.g., risk management, CAPA, data security).

A comprehensive toolkit for medical device manufacturers seeking ISO 13485 certification. This skill guides users through gap analysis, creating mandatory Quality Management System (QMS) documentation, and ensuring compliance with global medical device regulations (e.g., EU MDR, FDA QMSR). It provides templates, guidance, and structured processes for foundational QMS documents like Quality Manuals and CAPA procedures.

A comprehensive simulation of a General Counsel's (GC) review process. It interrogates contracts, term sheets, and agreements across critical legal domains: IP ownership, liability caps, data privacy (GDPR/CCPA), regulatory compliance (HIPAA/FDA), and employment structure. Use this before signing major agreements or entering new markets to identify hidden legal and operational risks.

A comprehensive simulation tool designed to pressure-test medical device manufacturers' Quality System Regulation (QSR) compliance against FDA standards (21 CFR 820). It covers six critical areas: complaint handling, process validation, device history records (DHRs), CAPAs, labeling, and handling of Form 483 observations. Essential for pre-inspection readiness, internal audits, and regulatory submission planning.

This tool performs a rigorous, simulated Quality Management System (QMS) audit based on ISO 13485 standards for medical devices. It forces interrogation on critical areas, including Design History Files (DHF), CAPA effectiveness, process validation, risk management (ISO 14971), and post-market surveillance (MDR/FDA QSR). Use it before major audits, commercial launches, or regulatory submissions to identify compliance gaps.