Medical Device Usability Study

Medical Device Manufacturers must complete the Usability Study for the product before launching it to the market, in accordance with the structure of the medical device they produce.

The goal of the usability study is to prove that the product can be easily, smoothly, and safely used by the intended users. This should be demonstrated through the Usability Study. The main standard for Usability Studies in medical devices is the EN 62366 Standard. If the product is an electronic medical device, the Usability Study must be conducted in accordance with the EN 60601-1-6 Standard.

During this study, Instructions for Use and any potential problems that may arise during use, along with their solutions, should be identified. Finally, through critical usage scenarios, the product’s safe and seamless use should be validated with selected reference users.