Medical devices are no longer judged solely by performance. Under stringent regulatory scrutiny and rising user expectations, usability has become the new benchmark for safety, market acceptance, and long-term success.
This eBook offers a decisive look at how Human Factors Engineering (HFE) is reshaping the development process for medical devices. It is not a theoretical overview but a practical framework grounded in real-world application and global regulatory standards.
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What You’ll Learn:
- Why nearly 28% of device-related adverse events are linked to usability failures—and how to prevent them
- How to systematically integrate usability into your development process to reduce risk and avoid costly rework
- What global regulators (FDA, EU MDR, Health Canada) now demand in usability validation
- How to leverage usability as a market differentiator, not a compliance checkbox
- Where the industry is headed: AI interfaces, immersive testing environments, and the evolving role of HFE
This guide is for regulatory leaders, design heads, and decision-makers who understand that safety and usability are inseparable and that every interface is a risk or a competitive edge.
Download the eBook now to align your development strategy with global best practices and gain the clarity to confidently move from concept to market.
