Skill UI

A comprehensive guide for Corrective and Preventive Action (CAPA) management within Quality Management Systems (QMS), specifically tailored for medical devices. It covers the entire investigation lifecycle, including root cause analysis (RCA) using methodologies like 5-Why and Fishbone diagrams, developing robust corrective actions, and verifying effectiveness to ensure continuous compliance and quality improvement.

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.

PyTorch Lightning is a high-level framework built on PyTorch that significantly reduces boilerplate code in deep learning training loops. It automatically handles device management, distributed training (DDP, FSDP, DeepSpeed), mixed precision, and advanced callbacks. It allows researchers to scale models from local machines to supercomputers with minimal code changes, enabling clean, scalable, and best-practice deep learning implementations.

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 skill guides the configuration and usage of Hardware Security Modules (HSMs) for robust cryptographic key management. Utilizing the industry-standard PKCS#11 interface, it covers key generation, signing, encryption, and key management directly on hardened physical or soft devices. It is essential for applications requiring the highest level of key protection, ensuring that private keys never leave the secure hardware boundary.

This guide outlines how to implement Google Cloud Identity-Aware Proxy (IAP) to enforce zero-trust, identity-based access control across various Google Cloud services (App Engine, Cloud Run, GKE, Compute Engine). It details configuring per-request authentication, context-aware policies (like device posture and location), and programmatic access management for highly secure internal applications.

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 to configuring secure OAuth 2.0 authorization flows, covering best practices for Authorization Code with PKCE, Client Credentials, and Device Authorization Grant. Learn how to implement mandatory security controls, manage token lifecycles, and align with OAuth 2.1 standards to build robust identity and access management systems.

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.