• Journal of Biomedical Engineering Research
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• v.43 no.4
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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.

• Journal of the Korean Society of Safety
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• v.36 no.1
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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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• v.10 no.2
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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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• v.40 no.4
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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.

• The Korean Journal of Financial Management
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• v.20 no.1
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• pp.261-277
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• 2003

The Korean Stock Market Surveillance System is desinged to control the volatility of stocks by drawing investor's attention and suppressing disguised demand, when stocks run up so rapidly in short period of time. Yet the Surveillance System has not been under empirical examination about its role and evolved in line with the Price Limit System. This study looks at the security returns under surveillance designation for 1995 -2001 period. The results indicate that the volatility of stocks has not been affected after surveillance designation. The constraints against the disguised demand, however, seems to limit the security returns rather than volatilities. These findings raises a question about the role of The Korean Stock Market Surveillance System for the control of volatility. The Surveillance System needs to be examined thoroughly about its role, function, and its conditions. Otherwise, the shareholders with less information could be placed at a disadvantage. This paper suggests that the system should be amended in an effort to make the volatility of stocks under control.

• Journal of Institute of Control, Robotics and Systems
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• v.21 no.11
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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.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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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.

• Korean journal of communication and information
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• v.64
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• pp.5-30
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• 2013

This paper conceptualizes the two-faced platform based on interface studies and two-sided market theory to critically analyze today's information technology culture such as the Internet. With this conceptual framework, the Internet can be investigated to have two faces, in which the square of user's openness, sharing, and participation is unfold on the front face, whereas the market of tracking, surveillance, and control of user's activities is formed on the other face. The two faces contradictorily coexist, resulting in technological and cultural dynamics on the Internet. Therefore, the Internet today as a two-faced platform can be described as a square-market interface. By analyzing on transformation of the web architecture, shift of informational commodity from content to data, and web bugs' user tracking across two faces, it examines how the world wide web itself can function as a two-faced platform. Lastly, implications and further works are suggested to improve the two-faced platform as a conceptual framework and to deeply analyze broader information technology culture based on it.

• International Journal of Fuzzy Logic and Intelligent Systems
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• v.15 no.3
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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.

• The Journal of Fisheries Business Administration
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• v.29 no.2
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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.