AI, Cyber, and the Medical Devices Mandate: The New High-Risk Regulatory Landscape
This guide was published on 9th December, 2025. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.
The medical device industry is undergoing a profound digital transformation, driven by the ubiquitous integration of Artificial Intelligence (AI), software, and connectivity into all aspects of healthcare.
AI, Cyber, and the Medical Devices Mandate: Guide Overview
This transformation introduces powerful new capabilities – such as real-time patient data monitoring and predictive diagnostics – but also creates significant regulatory challenges. Consequently, compliance is no longer a simple technical requirement but a strategic enabler for MedTech innovation and global market access.
Based on our recent webinar held in November ‘Medical Devices in the Age of AI and Cybersecurity: Regulatory Insights‘, this guide offers an essential roadmap for navigating this evolving landscape, focusing on the interwoven mandates of AI governance, cybersecurity, and data protection.
This Guide Covers
- The Digital Transformation of MedTech
- Regulatory Convergence in Medical Devices
- AI in Medical Devices: Distinctions and Risk Classification
- Cybersecurity: The Mandate for Security-by-Design
- Data Protection and Governance: The GDPR Foundation
- Global Compliance Strategies
- Future Trends and Regulatory Outlook
- Webinar Q&A: Real-world Questions on Medical Devices Answered
Authors
Fernanda Paro,
Regulatory Compliance Specialist
Fernanda is a Regulatory Compliance Specialist within the Global Regulatory Compliance Team, serving as the primary Subject Matter Expert (SME) for Medical Devices.
She specializes in monitoring and analyzing regulatory updates across various Latin American countries. Fernanda holds a Master’s Degree in International Trade Law with a focus on Medical Devices, Data Protection, and Cybersecurity.
As a qualified lawyer registered in both Brazil and Portugal, she brings extensive expertise in navigating complex regulatory landscapes to ensure compliance and strategic alignment.
Patricia Weathers,
Regulatory Compliance Specialist
Patricia brings over ten years working in Quality Compliance and Assurance for automotive components and medical device manufacturers, and is a Lead Auditor for ISO 9001 and ISO 13485. Prior to working in Quality-related roles, she provided research and information services at the US academic level and also coordinated corporate training development.
December 10th, 2025
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