U-Healthcare Medical Device?
Based on wired and wireless communication infrastructure, It is a medical device that enables medical personnel to remotely monitor patients' biological signals measured in real time in non-medical places, manage their health, and provide appropriate health care services in a timely manner.
Recently, the Ministry of Food and Drug Safety published guidelines for quality control applying the usability requirements among the “U-Healthcare electrocardiograph” medical device GMP standards.
Usability is a characteristic of the user interface that facilitates the use of a medical device in its intended use environment, thereby achieving safety, effectiveness, efficiency, and user satisfaction. All medical devices are subject to usability application in KGMP audit.
The usability engineering process is as follows.
1) Preparation of specifications for use
2) Identify user interface characteristics related to safety and potential usage errors
3) Identify known or predictable hazards and hazard situations
4) Identify and explain risk factors-related usage scenarios
5) Selection of hazard-related use scenarios for summative evaluation
6) Establishment of user interface specifications
7) Establish a user interface evaluation plan
8) Perform user interface design, implementation, and formative evaluation
9) Conduct a usability summative evaluation of the user interface
Medical device GMP usability must be performed based on the international standard IEC 62366-1 or equivalent standards.
Please refer to the file below for details.
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