• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• Journal of the Korea Society of Computer and Information
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• v.23 no.9
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• pp.107-112
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• 2018

Smart livestock has been proposed as a solution to increase farmers' income and new recruitment of livestock farmers. In this paper, a standardization Plan of breeding management device and collected information for smart livestock cattle was proposed. l Sophisticatedly, basic information will be established for all six types of livestock breeding management device: military automatic feeder, calf automatic feeder, smart milk cooler, feed bin to be able to measure feed residue, smart scale, and biometric information collection device. The standardization, common use, and stabilization of major livestock management device and collected information were suggested to solve the problems caused by in existing breeding management device.

• Convergence Security Journal
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• v.11 no.4
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• pp.67-75
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• 2011

Recently, the number of smartphone users is rising rapidly due to an influx of foreign smartphones and sales of domestic products. According to the increase of smartphone users, smartphone malwares are also increasing sharply. Hence it is necessary to protect smartphone against mobile malwares. There are device management protocols as SNMP, TR-069. But these protocols are not suitable for mobile device management because of restrictive management function and unsupported mobility. OMA DM which is a standard for mobile device management has been adopted as mobile device management protocol for most of 2G,3G. Thus it amounts that OMA DM is suitable for smartphone management system. In this paper, the mobile device management system based on OMA DM is designed. This system can remove smartphone malware by remote control.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2012.10a
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• pp.495-497
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• 2012

Development of application risk management for medical device software test. First, Through questionnaires, Medical device manufacturers, Analysis of software validation and risk management status. Second, Analyzed by comparing the difference between black box testing and white box testing. Third, After analyzing the potential for software analysis tools using code derived factors were quantified, Finally, Medical device risk management process so that it can be applied to build the framework by FMEA(Failure Mode and Effect Analysis) technique. Through this Difficult to build software validation and risk management processes for manufacturers to take advantage of support in medical device GMP(Good Manufacture Practice).

• Journal of Internet Computing and Services
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• v.13 no.1
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• pp.75-81
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• 2012

Previous RFID systems exclusively manage the tags and readers for each company in individual manner. Thus, RFID system manager should understand and design specifications such as tag events, data format, and etc, based on individual companies. But it is very difficult to know all statements. To resolve theses problems, there has been conceptual research about policy-based RFID service management model that is not restrained from standards of typical RFID systems, including EPCglobal standard, and ISO/IEC standard. However, previous proposed service management model only aimed event management without including device management. Therefore, in this paper, we propose extended device management policy model for giving shape to the proposed policy-based RFID service management model. If the proposing device management policy model is used for device management, we can integrate control management for heterogeneous middleware, diverse RFID devices, and applications for each company. Moreover, we show that the RFID device management policy is translated and processed as an example using the proposing policy model in real-time RFID system.

• Journal of Biomedical Engineering Research
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• v.40 no.1
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• pp.20-31
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• 2019

Medical device performance management is an activity that allows a device to be safely used and maintained even after it is put on the market. The purpose of this study is to provide procedures and criteria for selection of medical device items that should manage the safety and performance among medical devices in hospital. Investigate the performance management status of medical devices in hospitals and identify the performance management status by domestic and advanced regulatory agencies. Provides selection procedures and test methods for medical devices subject to performance management in hospitals based on medical device risk management and reliability. In addition, a case study on drug infusion pumps was conducted.

• Proceedings of the Korean Institute of Building Construction Conference
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• 2018.11a
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• pp.55-56
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• 2018

In order to reduce the risk of accidents, we proposed a construction safety management system combined with wearable device and LoRa (Low-Range Wireless Network) communication method to apply the usefulness of Internet (IoT) technology which means "everything connected". to construction safety management Management system. The proposed wearable safety device is a device that relays information exchange between wearable safety device and safety management server by LoRa wireless communication method. The safety management server can store workers bio-data and perform big data analysis. If a risk factor is determined from the analysis result, a warning is sent to the wearable safety device and the manager's application. The goal of this system is to prevent construction workers from entering the dangerous area that is not suitable for work, and to prevent safety accidents caused by human cause by detecting abnormal condition during work.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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• pp.503-515
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• 2022

Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

• Journal of Biomedical Engineering Research
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• v.44 no.2
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• pp.99-108
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.41-52
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• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.