• Title/Summary/Keyword: R&D Quality

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Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software

  • Kim, DongYeop;Lee, Byungjeong;Lee, Jung-Won
    • Journal of Internet Computing and Services
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    • v.20 no.3
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    • pp.69-75
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    • 2019
  • The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.

A study on the comparison of the predicting performance of quality of injection molded product according to the structure of artificial neural network (인공신경망 구조에 따른 사출 성형폼 품질의 예측성능 차이에 대한 비교 연구)

  • Yang, Dong-Cheol;Lee, Jun-Han;Kim, Jong-Sun
    • Design & Manufacturing
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    • v.15 no.1
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    • pp.48-56
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    • 2021
  • The quality of products produced by injection molding process is greatly influenced by the process variables set on the injection molding machine during manufacturing. It is very difficult to predict the quality of injection molded product considering the stochastic nature of manufacturing process, because the process variables complexly affect the quality of the injection molded product. In the present study we predicted the quality of injection molded product using Artificial Neural Network (ANN) method specifically from Multiple Input Single Output (MISO) and Multiple Input Multiple Output (MIMO) perspectives. In order to train the ANN model a systematic plan was prepared based on a combination of orthogonal sampling and random sampling methods to represent various and robust patterns with small number of experiments. According to the plan the injection molding experiments were conducted to generate data that was separated into training, validation and test data groups to optimize the parameters of the ANN model and evaluate predicting performance of 4 structures (MISO1-2, MIMO1-2). Based on the predicting performance test, it was confirmed that as the number of output variables were decreased, the predicting performance was improved. The results indicated that it is effective to use single output model when we need to predict the quality of injection molded product with high accuracy.

A Converged Study about Influences of Job Stress, Job Security, Depression, Family Bond, Subjective Health Status, Social Support on Quality of Life in Married Middle-Aged Male (기혼 중년 남성의 직업스트레스, 직업 안정성, 우울, 가족유대감, 주관적 건강상태, 사회적 지지가 삶의 질에 미치는 영향에 대한 융합적 연구)

  • Kim, Hyang-Soo;Kim, Song-Soon
    • Journal of the Korea Convergence Society
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    • v.8 no.3
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    • pp.101-114
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    • 2017
  • This is the study of descriptive research to look into influence factors about how married middle-aged male' job stress, job security, depression, family bond, subjective health status and social support have an effect on the quality life. We collected data by giving questionnaires to 149 middle-aged males between the ages of 40 to 49, living B & D metropolitan city and J city, and used the SPSS/WIN18.0 version to analyze. The correlated factors of quality of life included job stress(r=-.544, p<.001), depression(r=-748, p<.001), job security(r=.566, p<.001), subjective health status(r=.537, p<.001), family bond(r=.712, p<.001) and social support(r=.739, p<.001). Factors influencing quality of life are depression, social support, family bond, subjective health status, current employment period and regular exercise. Therefore, a good quality middle-aged life, it will be needed to lower the depression, expand the social support system, improve family bond and subjective health status, increase employment period.

A Study on the Analysis and Improvement of Defense Technology Planning in Response to the Fourth Industrial Revolution (4차 산업혁명 대응을 위한 국방기술기획 분석 및 개선방안 연구)

  • Noh, Sang-Woo;Song, Yu Ha;Choi, Jong-Min
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.4
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    • pp.551-556
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    • 2018
  • With the rise of the fourth industrial revolution, the importance of establishing R&D strategies to develop ICT technologies such as Big Data, Artificial Intelligence, Robots, the Internet of Objects, and 3D Printing is increasing. In this study, we analyzed the effects of the fourth industrial revolution on society and the present state of the national defense technology planning system, and proposed improvement measures for the utilization of the fourth industrial revolution in the defense industry from the perspective of defense R&D. The current defense R&D strategy focuses on securing the core technologies of each weapon system required by the military through research and development. Under the current system, the role of fourth industrial revolution technology will be confined to some of the weapons systems required by the military. In order to overcome this limitation, we propose a technology roadmap for the future weapons systems.

Analysis and Application Methods of Patent Map for Performance Diffusion of Translational Research in Health Technology Research and Development (보건의료 R&D 연구성과 활용·확산을 위한 특허맵 분석 및 활용방안 연구)

  • Cheon, Su-Hwan;Lee, Kyung-Min;Kim, Mi-Kyoung;Je, Young-Tae;Shin, Sang-Hun;Kim, Myung-Hwan;Kim, Dong-Seok;Park, Seong-Ho;Kim, Gi-Tae;Kwak, Jung-Ae;Jeon, Hye-Kyoung;Kwon, Jun-Young;Kim, Dong-Il;Kim, Byung-Soo;Park, Noh-Hyun
    • KSBB Journal
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    • v.28 no.6
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    • pp.339-348
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    • 2013
  • Translational research (TR) as high quality research can accelerate collaboration strongly between biotechnology-based researchers and clinical-research experts for overcoming diseases. TR facilitates basic science translated to clinical efficacy and effectiveness from bench (basic science) to bedside (clinical practice) for the enhancement of human health. Disease-oriented TR programs were defined as unilateral, bilateral and multilateral TR in this patent performance analysis. Patent performance was measured in a R&D project on Health and Medical Technology to enhance the productivity of R&D investment on disease-oriented TR in Health Technology (HT). Patent Map (PM) analysis and Bibliometrics were conducted to collect information for the assessment of research patents of TR programs. Futhermore, PIAS (Patent Information Analysis System) and Thinklear programs were applied for quantitative and qualitative analysis successfully. These indicate that multi-dimensional analysis of patent performance for disease-oriented TR could promote the connection of R&D-IP (Research and Development-Intellectural Property) and R&BD (Research and Business Development) supporting system significantly.

A Priority Analysis of Excellent Agricultural R&D Performance Considering Region-wide Diffusion Effect (지역파급성을 고려한 농업R&D 우수성과 순위 분석)

  • Yun, Jin-Woo;Chae, Yong-Woo;An, Yong-jin;Kim, Seong-Sup
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.4
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    • pp.471-478
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    • 2020
  • This study aimed to suggest implications for the future development of agricultural R&D through a priority analysis of excellent agricultural R&D performance considering productivity, marketability, and effects on region, which are important factors of agricultural R&D evaluation. The subjects of analysis were R&D of Rural Development Administration (RDA), which was selected as national R&D excellent Performance from 2006 to 2018, and the priority was analyzed using Analytic Hierarchy Process (AHP). The results are as follows. First, the relative importance of the criteria decreased in the order of marketability(0.423) > regional impact(0.360) > productivity(0.216). Second, as a result of analyzing the relative importance of the sub-criteria, the possibility of commercialization(0.515) was high in the category of marketability. The possibility of technology expansion(0.538) was high in the category of effects on region and the quality improvement(0.464) was high in the category of productivity. Third, the excellent agricultural R&D performance that had high relative importance was the technologies associated with improving the agricultural competitiveness of horticultural crops.

Reuse of Petroleum Refinery Wastewater Using Reverse Osmosis Membrane (역삼투막을 이용한 정유산업 폐수 재활용 연구)

  • Hwang, Jong-Sic;Sang, Byoung-In;Yoo, Je-Kang;Lee, Kyu-Hyun;Min, Byoung-Ryul;Kim, Byoung-Sik
    • Membrane Journal
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    • v.4 no.4
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    • pp.213-220
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    • 1994
  • Reverse osmosis(R/O) pilot system, which consists of pretreatments and R/O membranes, was demonstrated to regenerate the petroleum refinery wastewater for the process feedwater supply. Despite of the unsteady quality of the wastewater effluent from the process facilities, relatively high salt rejection of 96~99% was obtained and the product water showed a feasible quality for the use of cooling tower feed water. The results of R/O membrane module cleaning with NaOH solution represented that there was some fouling effects on the membrane performance during the period of test due to the ineffective treatment processes proposed and used in this study.

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A Study on Quality Assurance in Auto-parts Research & Development Stage with APQP and DFSS (APQP와 DFSS를 연계한 자동차부품연구개발 단계에서 품질보증에 관한 연구)

  • Lee, Kang-In;Kim, Jae-Hyu
    • Journal of Korean Society for Quality Management
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    • v.39 no.1
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    • pp.131-140
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    • 2011
  • Today, due to the global recession car sales have been decreased rapidly and auto makers are competing continuously to expand their market share. Automakers are struggling in order to secure competitive cost and quality through continuous cost reduction and quality innovation activities to win in the competition. In this situation, auto parts makers are trying to reinforce price competitiveness by reducing COPQ (Cost Of Poor Quality) in the mass production stages by securing the quality of components in advance from the design stage through DFSS (Design For Six Sigma) activities which is 6 sigma approach in the R&D field. However, auto parts makers have been undergone various confusion, feeling difficulties to get interrelationship among various activities. Thus, this study is going to suggest approach method for much more effective R&D activities by securing interrelationship between ISO/TS 16949 system established in the auto parts industry and DFSS activities.

Continuous Quality Improvement of Medical Equipments Based on Clinical Monitoring: A Case Study of Dental Implants (의료기기에 대한 임상모니터링 기반의 지속적 품질개선: 치과용 임플란트의 사례)

  • Kim, Myung-Duk;Eom, Tae-Gwan;Kim, Young-Jin
    • Journal of Korean Society for Quality Management
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    • v.36 no.2
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    • pp.59-66
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    • 2008
  • Dental implant has recently become one of the most viable treatment options for regaining the oral function and dental aesthetics compared with conventional fixed or removable dentures. Dental implants vary in material, dimensions, geometries, surface properties, and interface geometries. It has been reported that there has been a proliferation of manufacturers who produce implants using various materials and surface treatments, and the dentist needs to select from over 2,000 different dental implants and abutments in a specific treatment situation. Unfortunately, however, no metrics have been specifically identified for the purpose of quality assessment and selection of an appropriate dental implant. This study aims to provide practical guidelines for quality assessment of dental implant based on clinical data. Like other medical devices and materials, the superiority related to specific characteristics of the dental implant needs to be verified through extensive clinical studies. The procedures of clinical monitoring for dental implants have been proposed along with a case study to exemplify the usefulness of clinical monitoring for the purpose of continuous quality improvement in medical industry.

A Study on the Development of Evaluation Indicators for the Proposals of National Defense Core-Technology R&D Projects (국방핵심기술 연구개발의 제안서 평가를 위한 평가지표 개발에 관한 연구)

  • Kim, Chan-Soo;Cho, Kyu-Kab
    • IE interfaces
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    • v.21 no.1
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    • pp.96-108
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    • 2008
  • This paper proposes the systematic design approach for developing the evaluation indicators that evaluate the candidate proposals in the national defense core-technology R&D projects. To improve the validity and fairness of the evaluation indicators, the existing evaluation process in a military and a public sector are surveyed and also the existing evaluation system of the core-technology R&D programs for the national defense is analysed and discussed. A new system for the evaluation indicators is designed by using the axiomatic design, factor analysis and the analytic hierarchy process. It is expected that the proposed evaluation indicators contribute to enhance the fairness and the reliability of the evaluation process for the proposal of the national defense core-technology R&D projects.