UI/UX redesign in
medical devices: Balancing innovation with regulatory compliance

Within the rapidly evolving medical device industry, User Experience Design serves as essential element for ensuring safety, usability, and regulatory compliance. As manufacturers strive to modernize technology, respond to user feedback, and maintain competitive advantage, UI/UX updates often become inevitable. However, these changes can have substantial regulatory consequences, potentially affecting multiple quality and compliance processes and necessitating repeated validation testing as well as new regulatory submissions.

This document explores the regulatory impact of UI/UX modifications, offering insights into why these updates matter and how to navigate compliance effectively.

Download the whitepaper to explore:

• Understand the stakes: Learn why UI/UX changes are not just design decisions but regulatory requirements that affect device safety and compliance.
• Stay ahead of regulations: Gain clarity on global regulatory frameworks like FDA and EU MDR and how they influence UI/UX updates.
• Plan proactively: Discover best practices and explore strategies for early regulatory alignment.
• Ensure market access: Understand how proper handling of UI/UX changes can prevent delays in approvals and maintain product competitiveness.