Medical device usability study
Medical device producers must complete the usability study in accordance with the structure of their medical device before releasing the product on the market.
The purpose of the usability study is to prove through it that the product can be used easily, trouble-free and safely by the determined users.
The main standard for the usability study in medical devices is EN 62366 standard and in case of an electronic medical device, the usability study must be done in accordance with the EN 60601-1-6 standard.
While conducting this study, instruction manuals, foreseen problems that may occur during usage and their solutions should be determined. Lastly, safe and trouble-free usage of the product should be verified over the referenced users that are chosen via the critical usage scenarios.