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 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.

A comprehensive guide for designing and managing document control systems for ISO 13485-compliant Quality Management Systems (QMS), specifically tailored for the medical device industry. This resource covers document numbering, version control, change management workflows, approval processes, and ensures compliance with rigorous standards like 21 CFR Part 11, including electronic signatures and audit trails.

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.

Guides medical device teams through preparing ISO 13485:2016 Quality Management System documentation by combining gap analysis, requirements references, templates, and step-by-step creation workflows for manuals, procedures, and compliance artifacts.

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.

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.

Organizes declared scope, controlled documents, risk files, traceability, and readiness evidence for ISO 13485, ISO 14971, ISO/IEC 17025, and ISO 15189 human review, with deterministic local checks and separate certification, accreditation, FDA QMSR, and EU MDR/IVDR evidence boundaries.