• 제목/요약/키워드: Establishment devices

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A Study on the Establishment and Operation of a Regulatory Response Framework in connection with the Regulatory Strength of the Licensing Policy for New Medical Devices -Focusing on the Application of FMEA- (의료기기 신제품의 인허가정책 규제강도에 연계한 규제대응 프레임워크 수립 및 운영에 관한 연구 - FMEA 적용을 중심으로 -)

  • Kim, Gyosu;Ru, Gyuha;Kim, Yeonhee
    • Journal of Technology Innovation
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    • v.28 no.4
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    • pp.1-26
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    • 2020
  • Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

THE SHORT-TERM REMOVABLE INTERMAXILLARY FIXATION CARE BY USE OF AN ADDITIVE INCISION & DRAINAGE ON THE ORAL LACERATION WOUNDS ADJACENT WITH MANDIBULAR COMPOUND FRACTURES: REPORT OF A CASE (하악골 복합 골절시 구내 열창부 상에 추가 절개 배농술을 이용한 단기간 가변적 악간고정 관리: 증례보고)

  • Mo, Dong-Yub;Yoo, Jae-Ha;Choi, Byung-Ho;Kim, Ha-Rang;Lee, Chun-Ui;Ryu, Mi-Heon
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.32 no.3
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    • pp.260-264
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    • 2010
  • Treatment of the mandibular fracture consists of reduction and fixation. The apparatus that is used to keep the jaws together during healing will often reduce the fracture as well. When the jaws are brought together and intermaxillary elastic rubber traction is placed, the occlusion of the teeth will help to orient the fractured parts into good position. Intermaxillary fixation, that is, fixation obtained by elastic bands between the upper & lower jaws to which suitable anchoring devices have been attached, will successfully treat most fractures of the mandible. Arch bars are perhaps the ideal method for intermaxillary fixation. Several types of ready-made arch bars are used. But, daily occupational life and oral hygiene is difficult to maintain during the period of longterm immobilized intermaxillary fixation (commonly 6-8 weeks), owing to malnutrition and emotional disorders in a position of the patient with mandibular fractures. Most mandibular fractures heal well enough to allow removal of fixation in about 6 weeks. Though there are many complications of mandibular fracture, such as infection, hemorrhage, trismus, paresthesia and nonunion, it is favorable to attain the short-term removable intermaxillary fixation care by use of an additive incision & drainage establishment on the oral lacerated wounds of adjacent mandibular compound fractures. The purpose of an additive incision & drainge establishment is the prevention of wound infection & nonunion by removing the hematoma & seroma in the fracture sites.

2003 Asia Pacific Microwave Conference (2003아시아 태평양 마이크로파 학술회의)

  • 김동일;이혁재;박동철;명로훈;윤상원;조영기;남상욱;윤영중;이해영
    • Proceedings of the Korea Electromagnetic Engineering Society Conference
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    • 2004.01a
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    • pp.1-226
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    • 2004
  • I. Title APMC'03(2003 Asia Pacific Microwave Conference) II. Objecuve $\bigcirc$Investigation of new trend in the field of microwave engineering $\bigcirc$Establishment of R&D track for wireless and high speed communication III. Scope of investigation $\bigcirc$R&D trend in various microwave engineering areas-Solid state Devices and circuits-Electromagnetic Field Theory-EMI&EMC-Phased & Active Array Antennas-Scattering & Propagation $\bigcirc$Discussions with various technical topics-New research & development topics-Establishment of wireless & high speed communications IV. Results During the conference, very active academic exchange were possible between Korean and foreign microwave engineering scholars. It was also possible to introduce the level and activities of Korean microwave engineering researches to foreign countries. Also, it was good opportunity to contact foreign scholars and researchers for valuable academic discussion using technical paper presentations and inquiries.

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The Efficient Education Program for the Activation of the ADR System (ADR제도 활성화를 위한 효율적인 교육프로그램에 관한 연구)

  • Lee, Kang-Bin
    • Journal of Arbitration Studies
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    • v.18 no.1
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    • pp.3-30
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    • 2008
  • This paper is to research the current status of ADR in Korea, the qualifications of mediator (or conciliator) and arbitrator, the ADR education program of major foreign arbitration-related institutions and the efficient management device of ADR education program for the activation of the ADR system. In 2007, arbitration applications received at the Korean Commercial Arbitration Board numbered 320 and the amount involved those cases was US$ 216 millions. Mediation applications received at the KCAB numbered 552 and the amount involved those cases US$ 29millions. As of December 2007, the total numbers of arbitrators on the KCAB Panel of Arbitrators was 978. There are no provisions for the qualification of arbitrator in the UNCITRAL Model Law on International Commercial Arbitration and Arbitration Act of Korea. The KCAB has the consolidation regulation of the Panel of Arbitrator of which purpose is to regulate the criteria and procedure regarding the drawing up and maintenance of the panel of arbitrators. The UK Chartered Institute of Arbitrators has the criteria and qualifications for membership of which three grades are associate, member and fellow. The American Arbitration Association has the qualification criteria for admittance to the AAA National Roster of Arbitrators and Mediators. The Japan Association of Arbitrators has the official authorization regulation for membership of which three grades are special associate, ordinary associate and fellow. The UK Chartered Institute of Arbitrators has the ADR education programs which are composed of the mediation courses and arbitration courses. The American arbitrators Association has the ADR education programs which are composed of in-person training and online training. The Japan Association of Arbitrators has the ADR education programs which are composed of the cultivation courses of conciliator and the practical training courses of arbitrator. The efficient management devices of ADR education program are as follows: the execution of official authorization system of arbitrator, the establishment of specialized division for training and official authorization, the establishment of ADR regular training courses, the publication of ADR training texts and obtaining of instructors, and the consolidation of regulations related to the official authorization of arbitrator and ADR training. In conclusion, for the activation of ADR system, the KCAB and Korean Association of Arbitrators should make further effort to provide the ADR regular education and training programs for potential and practicing conciliators and arbitrators.

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Study on the Legal Establishment of u-City Management Center ; Focusing on its Function and Location (u-City 통합운영센터의 제도적 정착방안에 관한 연구 ; 기능 및 입지를 중심으로)

  • Cho, Chun-Man;Kim, Jung-Hoon
    • Spatial Information Research
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    • v.17 no.3
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    • pp.269-276
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    • 2009
  • For the development and management of u-City(ubiquitous city), Ubiquitous City Construction Law was enacted(March 3, 2008) to form the legal basis of u-City plan, construction and managements afterwards. Among u-City elements, the u-City Management Center has its own meaning and importance in roles which are crucial to the u-City developments, and its legal establishment is one of the core u-City realization factors. The purpose of this study is to analyse its overall problem issues regarding the function and location of u-City Management Center and then to suggest the basic direction and enforcement strategies to form its legal basis. As a result, in order to enhance the possibility of successful realization of u-City Management Center, the classification and standardization of function type, allocation of detailed functions based on u-City project hierarchy, and practical definition and relationships among basic u-City components such as u-City Service and Infrastructure were suggested. Also, practical execution devices on revenue sources and private sector participation, as well as the legal basis stipulating the mandatory inclusion of u-City Management Center development for u-City projects, were suggested.

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The information process on labor and the protection of information human rights (노동정보처리와 정보인권보호)

  • 하우영
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.13 no.6
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    • pp.17-32
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    • 2003
  • The information drive of the businesses requires new alternatives in that the promotion of business efficiency through information process technologies ends up conflicting with the protection of information human rights on laborers' side. Nevertheless, apathy on information protection has a tendency to be distorted by the efficiency of the businesses. Should the capital and mass media warn economic red lights, political circles with uneasiness would ignore the significance of information protection on the behalf of business efficiency. Therefore, the importance of information protection is considered a smaller interest than that of business efficiency with the infringements of human rights on laborers' side arising. Informatization of the businesses along with the developments of information process technologies has enabled the management to monitor and control the behaviors of laborers. This new problem needs to establish both information protection mechanism and institutional devices to regulate those labor controls. The security of business activity without human rights infringement warrants both basic rights of the public and spirit of the Constitution. The study suggests the establishment and revision of laws suitable to the period of information human rights. On top of that, the establishment of the basic law for information protection of individuals' with the common principle that integrates the related laws and rules on-off line is needed. This will warrant the active participation of labor unions and create specific alternatives for information protection.

Musicals and Memories of the March 1 Independence Movement - Centered on the musical Shingheung Military School, Ku: Songs of the Goblin, Watch (기념 뮤지컬과 독립운동의 기억 -<신흥무관학교>, <구>, <워치>를 중심으로)

  • Chung, Myung-mun
    • (The) Research of the performance art and culture
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    • no.43
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    • pp.229-261
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    • 2021
  • On the musical stage in 2019, there were many works depicting the Japanese colonial period. This is due to 2019 the timeliness of the March 1st Movement and the centennial of the establishment of the Provisional Government of the Republic of Korea. The way of remembering and commemorating historical facts reflects the power relationship between memory subjects and the time, namely the politics of memory. Until now, stage dramas dealing with the era of Japanese rule have focused on the commemoration of modern national and national defense, including feelings of misfortune and respect for patriots. This study analyzed the metaphor of the memorials emphasized to the audience in the commemorative musicals Shingheung Military School, Ku: Songs of the Goblin, and Watch which were performed in 2019, and looked at how to adjust memories and memorials. The above works highlight the narratives of ordinary people as well as those recorded against the backdrop of the Manchurian Independence Movement and Hongkou Park, expanding the object of the commemoration. Through this, active armed resistance efforts, self-reflection and reflection were highlighted. The case of Shingheung Military School revealed the earnestness of ordinary people who led the independence movement through the movement of central figures. Ku: Songs of the Goblin revises memories by reproducing forgotten objects and apologizing through time slip. Watch has strengthened the spectacles of facilities through documentary techniques such as photography, news reels, and newspaper articles, but it also reveals limitations limited to records. In the 3.1 Movement and the 100th anniversary of the establishment of the Provisional Government of the Republic of Korea, devices that actively reveal that the "people's movement" is connected to the present. To this end, the official records reflected the newly produced values and memories and devoted themselves to the daily lives and emotions of the crowd. In addition, both empirical consideration and calligraphy were utilized to increase reliability. These attempts are meaningful in that they have achieved the achievement of forming contemporary empathy.

Study on Developing Assessment Guideline for Safety and Performance of Electric Cupping Apparatus (전동식 부항기에 대한 안전성 및 성능평가 가이드라인 개발연구)

  • Yi, Seung-Ho;Kim, Eun-Jung;Shin, Kyung-Hoon;Nam, Dong-Woo;Kang, Jung-Won;Lee, Seung-Deok;Lee, Hye-Jung;Lee, Jae-Dong;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • v.26 no.6
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    • pp.101-110
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    • 2009
  • Objectives : We developed and proposed a guideline for safety and performance assessment of electric cupping apparatus(Class 2 medical device). Methods : We drafted the guideline for safety and performance assessment of electric cupping apparatus by referring the existing standards and guideline, based on online questionnaire for Korean medical doctors and measurement data from commercially available products. Physical dimension of cups and inner vacuum pressure were acquired for the measurement in order to achieve the purposes. Results : This guideline only can be applied to electric cupping apparatus for enhancing blood circulation by employing negative pressure generated by electricity. Seven items of appearance and label, operation test of pump, variation test of input electricity, vacuum level test, vacuum sustain test, cup-size dependent test, noise level test are suggested for evaluation subjects and methods required for electric cupping devices. Requirements for the design and development of electric cupping devices are suggested: vacuum level indicator, vacuum generation rate, pressure control, valve detachment stability, cup comparability, safety measure, surge protection, user friendliness, instruction for use (IFU). Conclusions : We proposed a guideline for safety and performance assessment of electric cupping apparatus to improve the quality of relating products and aid the commercialization of them, by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

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An Establishment of Functional Test Facility for ICT-Convergence Equipment of Vessel : Focused on Maritime Digital Interfaces and Main Navigation Communication Systems (선박 ICT융합 장비 기능시험 시설 구축 연구 : 선박 디지털 인터페이스 및 주요 항해통신장비를 중심으로)

  • Hwang, Hun-Gyu;Kim, Bae-Sung;Woo, Snag-Min;Woo, Yun-Tae;Shin, Il-Sik
    • Journal of the Korea Institute of Information and Communication Engineering
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    • v.22 no.5
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    • pp.754-763
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    • 2018
  • The maritime ICT-convergence equipment are essentially required to a type approval (TA) certification that needs environmental and functional tests, to install in vessel. The environmental test is to experiment the possession for required durabilities of the target device in maritime environment, and the functional test is to check the required functions of target equipment based on international standard. In Korea, the environmental testing facilities amount to 227 sites, but there is no functional testing facility. Because of this, we establish a function test facility for the maritime ICT-equipment. In this paper, we analyze and design the functional testing requirement and required interlocking simulators for digital interfaces and navigation communication equipment. We propose the 2-steps of functional testing procedures, which are single test and integration test, to improve the reliability of testing result. The single test is to examine own functions of the target device, and the integration test is to check harmonized operation with other navigation and communication devices.

A Study on Regulatory Law for Management System of Combined Medical Device (결합 의료기기 관리제도의 규제관련 법률에 관한 연구)

  • Choi, Yong Jun;Choi, Mi Lim;Lee, Jeong Chan;Jung, Yong Gyu
    • Journal of Service Research and Studies
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    • v.4 no.2
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    • pp.1-10
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    • 2014
  • According to recent trends in technological advances and globalization, medical device industry may improve the constitution to meet worldwide medical equipment management system. Also it is holding a strand of mitigation to reach the level of international regulation. In addition, recent legislation tends are to stay limited ranges of industry regulations at least and take as open attitude for integration of new technologies combined medical devices. A greater environmental risk is not likely to work in medical technology, Combinded medical device is used as close to zero risk in most of the human body, which is classified as Class 1. Even medical device such as little or no risk in handling, it is possible to minimize the unnecessary administrative power and a waste of time to occur. For the medical device may be improving people's choices and access, medical equipment operator is expanding to include dealers, because this will be exalted to particular area of the business of the company. In this paper, we investigate the legal prerequisites for the establishment of a medical device. And propose improved regulations in topics in order to facilitate the repair and distribution markets for fair trade.

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