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How to Design Medical Device Usability
Are you planning to design and market a medical device, either a physical one or a SaMD (Software as a Medical Device)? According to regulatory requirements, considering usability is mandatory. You have to apply the IEC 62366-1 standard in the design and evaluation process – the primary purpose of usability is to consider patient safety.
Patient Safety is Supported by Usability Design
Usability is an important part of any device and software. When it comes to software development, the concept of usability is generally used to describe a smooth and pleasant user experience. In many cases, notifications and verifications are unnecessary and clumsy for the user experience. However, in the case of medical devices, such things can save lives.
In this white paper, you will learn about usability requirements for medical devices.