Marie Dorat

By: Marie E. Dorat Executive Summary ISO 27001 is the internationally recognized standard for establishing, implementing, maintaining, and continually improving an Information Security Management System (ISMS). It provides organizations with a systematic and risk-based approach to managing sensitive company and customer information. Key Benefits at a Glance: Significantly reduces information security risks and cyber incidents Builds customer and stakeholder trust through demonstrable security...

Prepared for: Industry Professionals and Market Entrants | Author: Marie E. Dorat Executive Summary The Middle East medical device market, particularly in the GCC countries, presents substantial opportunities for Class I and Class II devices. This comprehensive guide covers regulatory requirements, documentation strategies, and practical pathways for efficient market entry. The Middle East offers strong growth for Class I and Class II medical devices. Focus on risk-based registration, ISO...

By Marie Dorat, M.E. Dorat Consulting Hello everyone. If you’re in Medtech—whether you’re a manufacturer, quality leader, regulatory professional, or executive—I want to have a straight-talk conversation today. We’ve all seen the headlines. Connected devices, AI-powered tools, and the promise of better patient outcomes are exciting. But the risks? They’re real, growing, and hitting patients and companies hard. Being vigilant and proactive about cybersecurity and responsible AI use isn’t...