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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.

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.

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.

A comprehensive guide for deploying Cisco Duo Multi-Factor Authentication across diverse enterprise access points, including VPN, RDP, SSH, and web applications. This skill details advanced security practices, covering adaptive access policies, phishing-resistant authentication (WebAuthn/FIDO2), device health checks, and establishing robust identity and access management controls aligned with industry compliance standards.

This guide details the process of implementing Zscaler Private Access (ZPA) to replace legacy VPNs with a modern Zero Trust Network Access (ZTNA) framework. It covers deploying App Connectors, defining application segments, and establishing granular access policies based on user identity, organizational user groups, and detailed device posture checks (e.g., compliance, anti-malware status).

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.

This guide details how to implement Google's BeyondCorp Zero Trust Access Model. It moves beyond traditional network perimeters by enforcing identity-aware access controls using IAP, Access Context Manager, and device posture verification. Ideal for securing remote and hybrid workforces migrating to Google Cloud.

This skill guides the progressive adoption of the CISA Zero Trust Maturity Model (ZTMM) v2.0. It provides a comprehensive, structured roadmap for assessing and improving security architecture across five critical pillars: Identity, Devices, Networks, Applications, and Data. Learn to perform gap analysis and implement advanced controls needed to achieve optimal zero trust compliance.

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.