Medical devices continue to grow in complexity with continuous innovations. In addition, device users are becoming less skilled and are often the patients themselves. As a result, the latest requirements in the Medical Device Regulation (MDR), emphasises the usability of a medical device. It is critical for device manufacturers to demonstrate their device is easy to use and will result in minimal errors of use.
In this training course you will gain a comprehensive overview of human factors and usability for medical devices. You will examine the standard IEC 62366 that outlines the process you must follow to ensure your device is easy to use. You will examine how to design and evaluate a device and discuss how to manage the risk of use errors.