Usability

Usability is a critical factor in the design of medical devices, directly affecting patient safety and clinical performance. It is a key element of the device's operational profile and must be evaluated in accordance with the IEC 62366 standard, which outlines the best practices for the usability of medical devices.

We provide expert support in preparing comprehensive usability studies for medical devices, ensuring compliance with regulatory standards and optimizing the user experience to enhance safety and functionality.

Our services include the creation of a detailed test protocol and an extensive usability evaluation report, which are essential for demonstrating the safety and effectiveness of your device. These documents are crucial for regulatory submissions and product approvals.

The usability process is integrated with risk analysis, enabling us to assess and mitigate risks associated with user errors, ergonomics, and other factors that may affect device performance. Our aim is to identify and reduce risks, ensuring the device is as intuitive and safe as possible for users.

We offer usability evaluations in both the early stages of device design and during the advanced development phases, allowing for continuous improvement throughout the entire device lifecycle. By addressing usability concerns early on, we help reduce the likelihood of errors and ensure the device meets user needs and regulatory requirements.

We are dedicated to supporting you at every step, ensuring your medical device meets the highest standards for usability, safety, and regulatory compliance.”