Usability for Medical Devices and IVDs
- Ensuring Safe, Effective, and
User-Friendly Solutions
At GBA Key2Compliance, we recognize that usability testing is essential to ensuring medical devices are not only compliant but safe and user-friendly for all. We support you throughout the entire usability process – guiding you in evaluating how real users interact with your device, identifying potential issues in design or function, and helping you implement practical improvements before launch.
We help you meet the standards
Our experts provide hands-on assistance in planning and conducting usability studies, interpreting feedback, and documenting results to meet regulatory requirements like those in the EU Medical Device Regulation (MDR) and IEC 62366.
By partnering with us, you gain the confidence that your medical device is thoroughly tested for intuitive use, minimizing risk and enhancing patient safety. With GBA Key2Compliance by your side, you can ensure your product meets the highest standards for usability, reliability, and patient trust.