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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.

A comprehensive guide on deploying Cloudflare Access and Tunnel to establish a Zero Trust Network Access (ZTNA) solution. This method replaces traditional VPNs by securely exposing self-hosted internal applications (web, SSH, RDP) without opening inbound ports. It integrates identity-aware policies, device posture checks, and robust identity providers (Okta, Azure AD) for highly secure, least-privilege access.

A comprehensive guide for implementing enterprise-grade Security Access Service Edge (SASE) architectures using Palo Alto Networks Prisma Access. This skill covers configuring ZTNA connectors, GlobalProtect agents, security policies, and device posture checks (HIP) to provide unified, cloud-delivered security, replacing traditional VPNs and maintaining zero trust principles across remote and branch offices.

This guide details deploying Tailscale (or self-hosted Headscale) to create a WireGuard-based zero trust mesh VPN. It establishes encrypted peer-to-peer connections between devices, eliminating the need for traditional VPN servers. Features include identity-aware Access Control Lists (ACLs), subnet routing, and secure connectivity for compliance-driven architectures. Use this when enforcing granular, identity-authenticated access control.

This guide provides comprehensive techniques for detecting Layer 2 ARP poisoning and spoofing attacks. It covers monitoring gratuitous ARP floods, tracking IP-to-MAC mapping changes, and identifying rogue devices. Techniques include deploying ARPWatch, configuring Dynamic ARP Inspection (DAI) on managed switches, and using advanced Wireshark filters or custom Python scripts for robust security monitoring and incident response.

This guide details methods for detecting and mitigating OAuth token theft and replay attacks in cloud environments, specifically targeting Microsoft Entra ID (Azure AD). It covers protection against access token theft, Primary Refresh Token (PRT) abuse, and pass-the-cookie attacks. Users can leverage Conditional Access and Token Protection features to cryptographically bind tokens to devices, significantly enhancing cloud identity security and preventing session hijacking.

A comprehensive guide to implementing Google's BeyondCorp zero trust access model. This solution enforces identity- and device-aware access control using Cloud IAP and Access Context Manager, effectively replacing traditional VPN infrastructure. Use this to secure remote and hybrid access to GCP-hosted or on-prem applications by requiring granular device posture checks and strong user authentication.

This skill implements the CISA Zero Trust Maturity Model (ZTMM) v2.0. It provides a structured framework to assess, gap-analyze, and roadmap the adoption of zero trust architecture across five core pillars: Identity, Devices, Networks, Applications, and Data. It guides organizations from Traditional to Optimal maturity, aiding compliance with NIST standards and federal mandates.