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 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.

This router bundles 15 specialized compliance skills crucial for HealthTech and MedTech organizations. It provides structured guidance across major global regulations, including ISO 13485 QMS, EU MDR, FDA submissions, GDPR, and the EU AI Act. Use this when a compliance request is complex and needs to be accurately directed to a specific technical skill area (e.g., risk management, CAPA, data security).

A comprehensive guide to implementing AWS Security Hub for centralized security posture management. It enables the aggregation of findings from multiple AWS accounts, evaluates compliance against industry standards (like CIS, PCI DSS, NIST), and configures automated remediation workflows using EventBridge and Lambda for robust organizational risk management.

This skill guides the implementation and maintenance of compliance controls for North American Electric Reliability Corporation (NERC) Critical Infrastructure Protection (CIP) standards. It covers key areas including asset categorization (CIP-002), electronic security perimeters (CIP-005), system security management (CIP-007), and supply chain risk management. Use this when auditing, updating, or establishing compliance measures for Bulk Electric System (BES) cyber assets.

This guide details the comprehensive implementation of privileged session monitoring and recording using Privileged Access Management (PAM) solutions, such as CyberArk PSM. It covers essential steps including architectural routing, configuring keystroke logging, real-time risk analysis, and establishing secure, tamper-proof audit trails for critical administrative access (RDP, SSH, Databases). Essential for meeting strict compliance standards like SOX, HIPAA, and PCI-DSS.

This skill provides comprehensive security hardening guidelines for serverless compute platforms like AWS Lambda, Azure Functions, and Google Cloud Functions. It covers essential security pillars including enforcing least privilege IAM roles, integrating robust secrets management (e.g., AWS Secrets Manager), automating dependency vulnerability scanning within CI/CD pipelines, and implementing strict input validation to mitigate risks such as injection and credential theft. Ideal for DevSecOps practitioners and security architects.

Implements HashiCorp Vault's dynamic secrets engine to automatically generate, lease, and rotate short-lived credentials for databases (e.g., Postgres, MySQL), AWS IAM keys, and PKI certificates. This eliminates the risk associated with storing static secrets, ensuring compliance with zero-trust principles and automating the entire secret lifecycle.