Usability Test for Rehabilitation Medical Devices
Project Overview
Usability Test for Rehabilitation Medical Devices
Usability Test is an essential step in the regulatory approval process for rehabilitation medical devices.
It is a systematic evaluation of the user interface—focusing on effectiveness, efficiency, and user satisfaction—to ensure that users can operate rehabilitation devices safely and correctly.
Usability Test of rehabilitation medical devices examines the design with respect to potential use errors in the intended environment. Through formative and summative evaluations, manufacturers can develop and validate user-friendly interfaces that ensure safety and effectiveness.
Through this process, patient treatment outcomes and ease of use are improved, while product safety, reliability, and market competitiveness are also strengthened.
Objects of Evaluation
Usability Test applies to rehabilitation medical devices of all classes. As IEC 60601-1 is applied worldwide, usability evaluation is a mandatory requirement. This includes all types of rehabilitation devices, from personal-use to hospital-based systems.
Rehabilitation Medical Devices
- Rehabilitation medical devices classified under the Korean Medical Device Act (Regulations on Medical Device Categories and Classification).
- Rehabilitation digital medical products classified under the Korean Digital Medical Products Act (Regulations on Classification and Designation of Digital Medical Products).
Evaluation Method and Application Process
A variety of methods can be applied in Usability Test. The scope, content, and cost are determined through mutual consultation and agreement between the rehabilitation medical device manufacturer and the National Rehabilitation Center.
Manufacturers can choose the most suitable Usability Test methods in line with their device’s development and regulatory approval stages.
The duration may vary by evaluation method, but typically takes 3–6 months after signing the agreement.
Key Features of Usability Test Institutions for Rehabilitation Medical Devices
The National Rehabilitation Center is Korea’s only national central institution dedicated to rehabilitation, comprising a Rehabilitation Hospital, a Rehabilitation Research Institute, and specialized business divisions.
Since 1994, the Rehabilitation Hospital Division has been at the forefront of rehabilitation medicine in Korea, supported by over 30 years of clinical expertise and specialized care systems for various disability types. Our team—rehabilitation physicians, therapists, nurses, medical technologists, and speech-language pathologists—provides extensive experience in spinal cord injury, stroke, pediatric disabilities, and more. This strong clinical foundation enables us to create evaluation environments that reflect real-world conditions and user characteristics, ensuring reliable Usability Test for rehabilitation medical devices.
Established in 2008, the Rehabilitation Research Institute has worked closely with the Rehabilitation Hospital Division to advance research on motor and cognitive function improvement, disability-specific characteristics, rehabilitation technologies, and the usability and effectiveness of clinical programs and devices. Grounded in practical studies that reflect real patient experiences, the Institute strengthens the precision and reliability of Usability Test for rehabilitation medical devices.
The National Rehabilitation Center’s Usability Test Center for Rehabilitation Medical Devices conducts evaluations in line with IEC 62366 international standards. Leveraging close collaboration between experts from the Rehabilitation Hospital Division and the Rehabilitation Research Institute, the Center analyzes the safety and effectiveness of user interfaces for rehabilitation medical devices.
The Usability Test Center for Rehabilitation Medical Devices is located on the first floor of the Rehabilitation Research Institute.