There is a constant and increasing pressure to develop safe, effective medical devices. From increasing complexity in use environments, to regulatory scrutiny over human factors, manufacturers are being asked to prove more, earlier. Ensuring that your device can be used safely and effectively, by real people, in real scenarios, is no longer a final step—it’s foundational. But anticipating user error, aligning with IEC 62366, and managing risk at speed can be overwhelming without the right partner.

Eurofins Medical Device Consulting offers integrated usability and risk analysis services designed to support your device at every stage of development. We help you meet global regulatory expectations, reduce user error, and deliver devices that are safe, effective, and user-friendly.

Our process includes a detailed test protocol and an extensive usability evaluation report to demonstrate the safety and effectiveness of your devices. We address the usability early in the development, allowing for improvement throughout the entire device lifecycle. By identifying and mitigating possible user errors, ergonomics and other factors that may affect the device performance from the earliest stages, this reduces the likelihood of errors and drives continuous improvement. 

Risk analysis is conducted in line with regulatory compliance with usability standards (IEC 62366). We provide comprehensive documentation, including an accurate plan and final report, outlining how risks have been identified, evaluated, and controlled throughout development.