Skill UI

A comprehensive guide for achieving compliance with the EU MDR 2017/745. It covers crucial aspects including medical device classification (Annex VIII), developing technical documentation (Annex II/III), planning clinical evaluation (CER), and establishing post-market surveillance (PMS/PSUR) systems. Ideal for regulatory specialists preparing for Notified Body audits or needing to gap-check technical files.

Implements and maintains ISO 13485 QMS for medical device organizations, covering gap analysis, documentation control, internal audits, supplier qualification, and CAPA tracking to keep regulatory programs audit-ready.

Provides senior regulatory affairs guidance for HealthTech and MedTech firms, driving FDA 510(k)/De Novo/PMA submissions, CE marking, and multi-market access strategies while maintaining intelligence on evolving regulations.

Implement Okta as a centralized Identity Provider (IdP) for robust multi-cloud security across AWS, Azure, and GCP. This skill covers configuring Single Sign-On (SSO), deploying phishing-resistant Multi-Factor Authentication (MFA), automating user lifecycle management via SCIM, and enforcing adaptive access policies based on device posture and user risk, helping organizations achieve Zero Trust compliance.

This guide provides a comprehensive blueprint for implementing robust Data Loss Prevention (DLP) policies using Microsoft Purview. It covers the configuration of sensitivity labels (encryption, content marking) and the creation of custom DLP rules using regex patterns. The workflow extends to endpoint DLP deployment for controlling file operations on Windows and macOS devices, ensuring sensitive data protection across SharePoint, Exchange, and OneDrive. It leverages PowerShell and the Microsoft Graph API for advanced, programmatic compliance management.

This tool performs a rigorous, simulated Quality Management System (QMS) audit based on ISO 13485 standards for medical devices. It forces interrogation on critical areas, including Design History Files (DHF), CAPA effectiveness, process validation, risk management (ISO 14971), and post-market surveillance (MDR/FDA QSR). Use it before major audits, commercial launches, or regulatory submissions to identify compliance gaps.