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.

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 module is designed to document, track, and manage quality nonconformance issues found during manufacturing or process audits. It is essential for root cause analysis, implementing corrective and preventive actions (CAPA), and ensuring compliance with industry quality standards. Use it when recording deviations from specified requirements.

AWS Verified Access is a Zero Trust Network Access (ZTNA) service that provides secure, VPN-less connectivity to corporate applications hosted in AWS. It enforces granular, conditional access control using the Cedar policy language, verifying both user identity and device security posture in real-time before granting access to specific resources. Ideal for modernizing security architecture and meeting strict compliance requirements.

This skill provides a comprehensive guide to implementing application whitelisting using Windows AppLocker. It drastically restricts unauthorized software execution (malware, shadow IT) on Windows endpoints by enforcing strict application control policies. Use this method to meet critical compliance requirements (such as PCI DSS or NIST standards), block common attack vectors like LOLBins, and significantly reduce the overall attack surface in high-security environments.

Implement a comprehensive Cloud Security Posture Management (CSPM) solution across multi-cloud environments (AWS, Azure). This skill guides the use of industry tools like AWS Security Hub, Azure Defender for Cloud, Prowler, and ScoutSuite to continuously detect misconfigurations, compliance violations, and vulnerabilities. It is crucial for establishing robust, centralized security controls and meeting regulatory compliance requirements.

This skill provides comprehensive guidance on implementing Conditional Access policies within Microsoft Entra ID (Azure AD). It covers configuring zero trust access control, integrating signal-based policies, enforcing device compliance, and utilizing risk-based authentication. This is crucial for establishing robust security architectures aligned with NIST standards and regulatory compliance requirements.

This guide details the implementation of device posture assessment for robust Zero Trust Access Control. It outlines how to integrate endpoint health signals from multiple security platforms (CrowdStrike ZTA, Intune, Jamf) into conditional access policies. Users can enforce stringent compliance requirements—such as disk encryption, OS patch levels, and security sensor status—to ensure only compliant devices gain access to corporate resources.

This skill guides the implementation of full disk encryption using Microsoft BitLocker on Windows endpoints. It covers best practices for deploying encryption via GPO, Intune, and command line, ensuring data-at-rest protection. Use this when meeting compliance requirements (PCI, HIPAA) or securing mobile workstations against physical loss or theft.

This skill guides the implementation of File Integrity Monitoring (FIM) using AIDE (Advanced Intrusion Detection Environment). It covers setting up AIDE configurations, creating initial baselines, performing scheduled integrity checks, and parsing detailed change reports. This is essential for maintaining strong security controls, meeting compliance requirements, and detecting unauthorized system modifications on Linux environments.

This skill provides comprehensive guidance on configuring Fluentd and Fluent Bit for centralized log collection, routing, filtering, and enrichment. It covers setting up lightweight log forwarders on endpoints and designing central aggregators that route data to SIEM tools, Elasticsearch, or Splunk. Essential for achieving observability and meeting strict security compliance requirements.

This skill guides the design and implementation of robust network segmentation using firewall zones, VLANs, ACLs, and microsegmentation. Learn to build secure, isolated zones (like DMZ, PCI CDE, Management) to enforce least-privilege access, restrict lateral movement, and meet stringent compliance requirements (PCI DSS, HIPAA).