Embedding Usability into Medical Device Development: A Strategic Advantage for Compliance and Success
Designing a successful medical device goes far beyond technical functionality. Usability is now a core requirement in regulatory submissions and a key driver of product safety and effectiveness.
In this recorded webinar, experts from GSAP and ED&U guide you through the strategic integration of usability across the product lifecycle, starting from early concept development through to final regulatory submission.
🎯 What You’ll Learn:
• Key usability activities required for compliance with FDA, MDR, and other global regulations
• A step-by-step approach to integrating usability into the design and development process
• When and how to involve usability engineers and human factors specialists
• Practical tools, templates, and best practices for aligning with regulatory expectations
• How to create safer, more intuitive medical devices that meet clinical needs
Whether you’re working in R&D, regulatory affairs, quality assurance, or human factors engineering, this session will help you build user-centered devices that meet both clinical and compliance goals.
🎥 Watch the full recording below:
