• 대한의용생체공학회:의공학회지
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• 제44권1호
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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.

• 한국컴퓨터정보학회논문지
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• 제23권9호
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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.

• 융합보안논문지
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• 제11권4호
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• pp.67-75
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• 2011

최근 많은 외산제품들이 국내시장에 유입되고 국내 제품의 출시로 스마트폰 사용자는 급속히 증가하고 있다. 스마트폰 사용자가 증가함에 따라 모바일 악성코드 또한 빠르게 증가하고 있다. 이에 모바일 악성코드에 대한 적절한 대응의 필요성이 증대되고 있다. 단말 관리 방법으로는 SNMP, TR-069 프로토콜이 널리 사용되었지만 이들 프로토콜은 제한적인 관리기능, 이동성 미지원 등으로 인해 모바일 단말 관리에는 적합하지 않다. 모바일 단말 관리 표준인 OMA DM 프로토콜이 대부분의 2G, 3G 무선 단말들의 관리 프로토콜로 채택되고 있으며, 따라서 스마트폰 단말 관리를 위해서도 적합한 프로토콜이라 할 수 있다. 본 논문에서는 악성코드에 대한 현황을 설명하고 스마트폰의 악성코드를 원격제어로 제거할 수 있는 OMA DM기반의 단말 관리 시스템을 설계하였다.

• 인터넷정보학회논문지
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• 제13권1호
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• pp.75-81
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• 2012

기존의 RFID 시스템은 서로 다른 회사마다 각자의 방식으로 태그 및 리더를 관리한다. 따라서 RFID 시스템 관리자들은 개별적으로 존재하는 회사의 고유 태그 이벤트, 데이터 포맷 등의 규격을 각각 이해하고 설계해야 하는 어려움이 생기게 된다. 이를 보완하기 위해 EPCglobal 표준과 ISO/IEC 표준 등 기존의 RFID 시스템에 구속되지 않는 정책 기반 RFID 서비스 관리 모델이 제안되었다. 하지만 기존에 제안했던 서비스 관리 모델은 이벤트 관리를 목적으로 하고 있기 때문에 장치 관리 기능까지 포함하고 있지 않다. 따라서 본 논문에서는 제안된 정책 기반 서비스 관리 모델을 보다 구체화하여 확장된 장치 관리 정책 모델을 제안한다. 제안하는 장치 관리 정책 모델은 회사마다 상이하게 존재하는 미들웨어, 이기종 RFID 장치, 다양한 응용프로그램들에 대해 통합적으로 제어 관리를 수행 할 수 있도록 해준다. 또한 제안하는 정책 모델을 이용하여 RFID 장치 관리 정책이 RFID 시스템에서 실시간으로 변환되고 처리되는 과정을 예제를 통해 보인다.

• 한국정보통신학회:학술대회논문집
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• 한국정보통신학회 2012년도 추계학술대회
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• pp.495-497
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• 2012

의료기기 소프트웨어 테스트 위험관리 적용 방안에 대해 연구하였다. 먼저 설문조사를 통해 의료기기 제조업체의 소프트웨어 밸리데이션 및 위험관리 현황을 분석하고 두 번째로 블랙박스 테스트와 화이트 박스 테스트를 비교하여 차이점을 분석하였다. 세 번째로 소프트웨어 분석 도구를 활용한 코드 분석 후 잠재적인 위해요인을 도출하고 이를 정량화 하였으며, 마지막으로 도출된 위해요인을 FMEA 기법을 이용하여 의료기기 위험관리 프로세스에 적용할 수 있도록 프레임워크를 구축하였다. 이를 통해 의료기기 품질관리(GMP) 업무 중 소프트웨어 밸리데이션 및 위험관리 프로세스를 구축하기 어려운 제조업체를 위한 업무 지원에 활용하고자 한다.

• 대한의용생체공학회:의공학회지
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• 제40권1호
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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.

• 한국건축시공학회:학술대회논문집
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• 한국건축시공학회 2018년도 추계 학술논문 발표대회
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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.

• 품질경영학회지
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• 제50권3호
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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.

• 대한의용생체공학회:의공학회지
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• 제44권2호
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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.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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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.