• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Journal of Biomedical Engineering Research
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• v.44 no.5
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• pp.315-323
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• 2023

The objective of this study is to identify the selective application targets for reporting on details of supply of class 1 and 2 medical devices as part of the improvement of the reports on details of supply of medical device system, and to analyze its effectiveness. Therapeutic materials covered by health insurance and secondhand medical devices were chosen based on the transparency of health insurance coverage and the management of medical device distribution. As a result, approximately 85% of groups can be excluded from the reporting requirements compared to reporting all items under Class 1 and 2 medical devices. This is expected to enhance the efficiency of supply reporting tasks. Additionally, the information on supply details managed by the regulatory authority can be utilized for statistical analysis and periodic monitoring, serving as fundamental data for the development of medical device-related policies and research in the field of medical devices.

• The KIPS Transactions:PartC
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• v.15C no.1
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• pp.61-68
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• 2008

With the rapid advancement of mobile communication, mobile devices are evolving into convergence devices with various multimedia capabilities. But, high performance of devices demands complicated settings, and thus contains latent error possibilities, and poor system performance caused by the collision of different softwares. To solve these problems, device management becomes an important issue. Open Mobile Alliance(OMA) developed OMA DM(Device Management), which is a device management standard. Recently released OMA DM v1.2 provides improved mobile device management methods compared to earlier versions. This paper introduces design and implementation of OMA DM v1.2 based management agent. By using Tree and Description Serialization(TNDS) for acquiring, adding, and editing objects in the mobile devices, it provides more effective device management with small amount of network traffic.

• Journal of the Korea Safety Management & Science
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• v.20 no.2
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• pp.1-8
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• 2018

This study aims to provide a real-time information to the driver by effectively operating the advanced safety device attached to the freight vehicle, thereby minimizing insecure behavior of the driver such as speeding, rapid acceleration, sudden braking, And improve driving habits to prevent accidents and save energy. Advanced safety equipment is a device that warns the driver that the vehicle leaves the driving lane regardless of the intention of the driver and reduces the risk of traffic accidents by mitigating or avoiding collision by detecting a frontal collision during driving.The main contents of this report are as follows: In case of installing a warning device on a lane departing vehicle (excluding a light vehicle) and a lorry or special vehicle with a total weight exceeding 3.5 tonnes, the driver must continue to operate unless the driver releases the function.In addition, when the automatic emergency braking system is installed, the structure should be such that the braking device is operated automatically after warning the driver when the risk of collision with the running or stopped vehicle in the same direction is detected in front of the driving lane.

• Journal of Korean Society for Quality Management
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• v.46 no.2
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• pp.211-224
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• 2018

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2015.05a
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• pp.170-171
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• 2015

At the present time it continues to be the smart device released has also been commercialization device accessories accordingly. Such accessories are getting great response to consumers in the form of an external device to a character commercialization design. However, these products are not useful in the functional aspects of using the external form of the device is concentrated only. This study documents the management app to give the game character acts on the application category grouping the ability to efficiently manage the smart device. Research method is to study the existing product released to find out how it works come from the smart device management side, The device app management features added to the game play will be produced based on them.

• Journal of the Korean Graphic Arts Communication Society
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• v.25 no.1
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• pp.65-80
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• 2007

The input and output device requires precise color representation and CMS (Color Management System) because of the increasing number of ways to apply the digital image into electronic publishing. However, there are slight differences in the device dependent color signal among the input and output devices. Also, because of the non-linear conversion of the input signal value to the output signal value, there are color differences between the original copy and the output copy. It seems necessary for device-dependent color information values to change into device-independent color information values. When creating an original copy through electronic publishing, there should be color management with the input and output devices. From the devices' three phases of calibration, characterization and color conversion, the device-dependent color should undergo a color transformation into a device-independent color. In this paper, an experiment was done where the input device used the linear multiple regression and the sRGB color space to perform a color transformation. The output device used the GOG, GOGO and sRGB for the color transformation. After undergoing a color transformation in the input and output devices, the best results were created when the original target underwent a color transformation by the scanner and digital camera input device by the linear multiple regression, and the LCD output device underwent a color transformation by the GOG model.

• KIPS Transactions on Software and Data Engineering
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• v.6 no.12
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• pp.543-548
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• 2017

In recent years, the importance of the safety of medical device software has been emphasized because of the function and role of the software among components of the medical device, and because the operation of the medical device software is directly related to the life and safety of the user. To this end, various standards have been set up that provide activities that can effectively ensure the safety of medical devices and provide their respective requirements. The activities that standards provide to ensure the safety of medical device software are largely divided into the development life cycle of medical device software and the risk management process. These two activities should be concurrent with the development process, but there is a limitation that the risk management requirements to be performed at each stage of the medical device software development life cycle are not classified. As a result, developers must analyze the association of standards directly to develop risk management activities during the development of medical devices. Therefore, in this paper, we analyze the relationship between medical device software development life cycle and risk management process, and extract risk management requirement items. It enables efficient and systematic risk management during the development of medical device software by mapping the extracted risk management requirement items to the development life cycle based on the analyzed associations.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.39C no.1
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• pp.1-8
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• 2014

This paper proposed a method that prevents data leakage and modulation and detects an unauthorized device by using AP and mobile device. Most of existing method for detecting and preventing an unauthorized device are similar to type of Evil Twin. However, in previous studies can not resolve many security accident and have the problem to cope with effectively security accident on various network. In order to solve these problem, companies prepare security accident through the varies policy and guideline. but It is hard to prevent all security accident because it is consistently increasing everyday. This paper suggests technique of detecting and preventing an unauthorized device using Context Awareness and Mobile Device Management. Firstly, when mobile device go into internal network, server distinguish access permission and authorization of mobile device using acquiring the conetxt information of mobile device. By using this result, server applies the appropriate management technique to the mobile device for leakage and accident of internal network.

• Proceedings of the KIPE Conference
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• 2002.07a
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• pp.693-696
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• 2002

In this paper, network management system(NMS) was developed using Ethernet network for several devices. Recently, due to the development of the information communication, network has been constructed several place. And management system using network has been studied due to the increment of necessity of remote control for industrial device. Agent board that necessity of NMS, was developed using general micro-controller, it operates like stand-alone network device, supports TCP/IP protocol suite, has the ability to connect to industrial device and communicates each other. Also manager base on MMI was developed, it operates with agent board and supports effective management. To prove this system UPS(uninterruptible power supply) is selected as the example of industrial device. Finally, experimental result verifies the communication between agent board and manager.