Skill UI

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.

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.

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 guide details the comprehensive deployment of Cisco Duo Multi-Factor Authentication across critical access points like VPN, RDP, SSH, and web applications. It covers setting up the Duo Authentication Proxy, implementing adaptive access policies based on risk and device health, and deploying phishing-resistant methods like WebAuthn/FIDO2, ensuring compliance with NIST standards. Use this when hardening identity access management or establishing robust security controls.

This skill guides the implementation of Mobile Application Management (MAM) policies, enabling robust data protection for corporate assets on both managed and unmanaged mobile devices (BYOD). It covers configuring app-level controls such as Data Loss Prevention (DLP), selective wiping, and containerization using platforms like Microsoft Intune and Azure AD. Use this when enforcing data separation between personal and work environments without requiring full device enrollment.

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 provides comprehensive management capabilities for Cognitum Seed device fleets. Users can perform various actions such as creating new fleets, listing existing ones, adding or removing individual devices, and deleting entire fleets. It helps maintain firmware policies and manage the lifecycle of connected IoT devices.