• 대한의용생체공학회:의공학회지
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• 제43권4호
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• 한국안전학회지
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• 제36권1호
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• pp.26-35
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• 2021

Governmental bodies generally conduct investigations for product safety management once new products are released to the market, in order to prevent distribution of illegal and defective items. Further, market surveillance activities are regularly conducted by the government to ensure distribution of safe products and recall any hazardous products. The safety investigations often involve a consumer monitoring system wherein consumer organizations participate in market monitoring to conduct surveys on illegal and defective products. As a result, the monitoring results of individual consumer organizations are available separately, but an integrated analysis of the data from all consumer organizations cannot be performed, thereby deterring comprehensive evaluation of the consumer monitoring system. In this study, we analyze the individual monitoring results of consumer organizations to understand the overall status and performance of comprehensive market monitoring and present the directions for desirable market surveillance policies. To this end, the effectiveness of market surveillance related to the distribution of products is verified through analysis of the interrelationships between the monitoring processes and performances of consumer organizations as well as their impact on the performances of the monitoring implementation processes; moreover, several improvement points and direction points are presented for more desirable monitoring of the consumer markets.

• International journal of advanced smart convergence
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• 제10권2호
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• pp.45-52
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• 2021

The surveillance camera market has developed and plays an important role in the field of video surveillance. However, in recent years, the identification of areas requiring surveillance has been limited by reflective light in the surveillance camera market. Cameras using polarization filters are being developed to reduce reflective light and facilitate identification. Programs are required to automatically adjust polarization filters. In this paper, we proposed an optimal angle extraction method from surveillance cameras using polarization filters through histogram analysis. First of all, transformed to grayscale to analyze the specifications of frames in multiple polarized angle images, reducing computational throughput. Then we generated and analyzed a histogram of the corresponding frame to extract the angle when the highlights are the fewest. Experiments with 0˚ and 90˚ showed high performance in extracting optimal angles. At this point, it is hoped this technology would be used for surveillance cameras in place like beach with a lot of reflective light.

• Journal of Preventive Medicine and Public Health
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• 제40권4호
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• pp.278-284
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• 2007

Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

• 재무관리연구
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• 제20권1호
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• pp.261-277
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• 2003

한국주식시장의 감리종목 제도는 단기간에 주가가 급등할 경우 투자자의 주의를 환기하여 가수요를 억제함으로써 주가의 안정을 도모하고자 하는 거래 장치중의 하나이다. 그런데, 감리 종목 제도는 그 시장안정장치로서의 역할에 관하여 이렇다 할 실증적 검증 없이, 가격제한폭 제도가 변할 때마다, 그 지정 및 해제 기준을 임의로 변경시키면서 존속되어 왔다. 본 연구에서는 1995년부터 2001년까지 7년 동안, 감리종목으로 지정된 거래소종목과 코스닥종목의 수익률 자료를 조사하였는데, 감리종목 지정 후 원래의 취지와는 달리 주가의 변동성이별로 억제되지 않는 것으로 밝혀졌다. 가 매수 세력을 감소시키는 감리종목 제도의 조건들은 주가의 변동성보다는 오히려 수익률에 제약적으로 작용하여, 해당 주식들은 감리지정 후에 수익률이 감소할 가능성이 있는 것으로 나타났다. 감리종목의 지정 후 변동성이 억제되지 못하고 오히려 그 변동성이 증대되고, 수익률만 감소되는 결과로 나타난 것은 일관되게 감리종목 제도의 변동성 억제라는 기능에 의문점을 남긴다. 이는 가격제한폭 제도에 못지않게, 감리종목 제도도 그 취지와 기능, 조건 등에 있어서 검증이 되어야 함은 물론, 명확한 기준 없는 제도의 강화내지 완화는 시장의 안정성과 일반 투자자들의 투자 행태에 부정적인 영향을 미칠 수 있다는 것을 시사한다. 따라서 향후, 감리종목 제도는 단순히 수익률이 억제되는 방향보다는 취지대로 주가의 변동성을 감소시킬 수 있도록 계발되어야 할 것이다.

• 제어로봇시스템학회논문지
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• 제21권11호
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• pp.989-995
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• 2015

Due to the recent increase of the importance and demand of security services, the importance of a surveillance monitor system that makes an automatic security system possible is increasing. As the market for surveillance monitor systems is growing, price competitiveness is becoming important. As a result of this trend, surveillance monitor systems based on an embedded system are widely used. In this paper, an object detection algorithm based on an embedded system for a surveillance monitor system is introduced. To apply the object detection algorithm to the embedded system, the most important issue is the efficient use of resources, such as memory and processors. Therefore, designing an appropriate algorithm considering the limit of resources is required. The proposed algorithm uses two background models; therefore, the embedded system is designed to have two independent processors. One processor checks the sub-background models for if there are any changes with high update frequency, and another processor makes the main background model, which is used for object detection. In this way, a background model will be made with images that have no objects to detect and improve the object detection performance. The object detection algorithm utilizes one-dimensional histogram distribution, which makes the detection faster. The proposed object detection algorithm works fast and accurately even in a low-priced embedded system.

• 대한의용생체공학회:의공학회지
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• 제40권5호
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• pp.171-178
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• 2019

This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

• 한국언론정보학보
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• 제64권
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• pp.5-30
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• 2013

이 글은 오늘날 인터넷을 비롯한 정보기술문화를 비판적으로 분석하기 위한 개념틀로 이중적 플랫폼을 제안한다. 인터페이스연구와 양면시장론에 기대어 인터넷을 이중적 플랫폼으로 접근함으로써 전면에는 이용자의 공개, 공유, 참여의 광장이 펼쳐지고 이면에는 그에 대한 추적, 감시, 통제의 시장이 형성되는 복합적 양상을 분석할 수 있다. 특히 전면의 광장과 이면의 시장이 어떻게 하나의 플랫폼에서 공존하며 모순적으로 상호작용하는가에 초점을 맞추면서 인터넷의 이중적 플랫폼을 광장시장의 인터페이스로 규정할 것이다. 그에 이어 월드와이드웹의 설계구조가 바뀌고 콘텐츠에서 데이터로 정보재의 주요 상품 형태가 변천하며 이용자 추적을 위한 웹벌레의 기능을 분석하면서 웹 전체가 어떻게 이중적 플랫폼으로 기능하는지 규명한다. 마지막으로 이중적 플랫폼 개념틀의 함의와 추후 심화된 분석을 위해 필요한 과제를 제시한다.

• International Journal of Fuzzy Logic and Intelligent Systems
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• 제15권3호
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• pp.172-179
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• 2015

Because of the development of computers and high-technology applications, all devices that we use have become more intelligent. In recent years, security and surveillance systems have become more complicated as well. Before new technologies included video surveillance systems, security cameras were used only for recording events as they occurred, and a human had to analyze the recorded data. Nowadays, computers are used for video analytics, and video surveillance systems have become more autonomous and automated. The types of security cameras have also changed, and the market offers different kinds of cameras with integrated software. Even though there is a variety of hardware, their capabilities leave a lot to be desired. Therefore, this drawback is trying to compensate by dint of computer program solutions. Image processing is a very important part of video surveillance and security systems. Capturing an image exactly as it appears in the real world is difficult if not impossible. There is always noise to deal with. This is caused by the graininess of the emulsion, low resolution of the camera sensors, motion blur caused by movements and drag, focus problems, depth-of-field issues, or the imperfect nature of the camera lens. This paper reviews image processing, pattern recognition, and image digitization techniques, which will be useful in security services, to analyze bio-images, for image restoration, and for object classification.

• 수산경영론집
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• 제29권2호
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• pp.47-64
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• 1998

This paper seeks to find out possibility of introducing market order into Korean fisheries regulatory system. Hayek tells us that market order is equivalent to spontaneous order, while regulations are man-made order created based on incomplete knowledge. He also sees market competition as a discovery procedure of knowledge and information. From this perspective is discussed Korean fisheries regulatory reform-particularly issues of establishing property right on fishery resources. It appears that there is quite a large room for substituting market functions for the regulations regarding fishery resources management, even though fishery resources have a very nature of common pool. Advanced fisheries suggest that successful regulatory reform require a well-prepared strategic plan and check list. In addition, the government should be able to secure sufficient monitoring and surveillance power and to play an important role as a fair supervisor.