• Title/Summary/Keyword: 의료기기산업

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ISO14971:2019 detailed analysis and Post Market Surveillance Application Method - Focusing on IVDR requirements (ISO14971:2019 세부분석과 Post Market Surveillance의 적용 방안 - IVDR 요구사항 중심으로)

  • Knag, Il Kyu
    • 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.

Planning of Various Storytelling Virtual Reality Game Contents for Brain Enhancement (두뇌증진을 위한 다양한 스토리텔링 가상현실 게임 콘텐츠 기획)

  • Jin, Hwa-su;Song, Eun-jee
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2021.05a
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    • pp.323-325
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    • 2021
  • With the recent revitalization of virtual reality and game industries, digital therapeutics for medical purposes are emerging. Digital therapeutics refer to sports-based therapeutics such as virtual reality contents and games that are effective in preventing, managing, and treating diseases, not drugs. Through this study, we plan and develop contents for healing and brain enhancement using virtual reality technology as a therapeutic digital therapy. Through this, it can help to improve the brain of children who are dependent on electronic devices in the digital age and rarely use their brains.

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A Study of Metaverse and Security Issues (메타버스와 보안 이슈에 대한 고찰)

  • Cho, Eun-Young;Choi, Jae-Hong;An, In-Hoe;Lee, Jun-Dong;Ju, Yong-Wan
    • Proceedings of the Korean Society of Computer Information Conference
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    • 2022.01a
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    • pp.109-112
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    • 2022
  • 메타버스란 가상, 초월을 뜻하는 Meta와 우주, 세계를 뜻하는 Universe의 합성어로 가상과 현실이 상호작용 하면서 사회·경제·문화 활동이 이루어지며 가치를 창출하는 세상을 말한다. 이러한 메타버스는 5G와 그래픽 기술의 발전과 함께 코로나 사태로 인한 비대면 생활이 계속되면서 디지털 네이티브 세대인 Z세대가 메타버스 플랫폼을 소통의 장으로 삼기 시작하면서 성장하고 있다. 메타버스 안에서 콘서트나 사인회를 하고, 가상 아이템을 판매하며 마케팅을 벌이는 등 다양한 산업에서 메타버스에 뛰어들고 있다. 점점 진화하고 있는 메타버스는 메타버스 내에서 유저들 간에 맺는 상호관계 활동이 큰 장점이지만, 이로 인해 개인정보 보호 문제나, 위치정보, 금융정보 문제 등의 다양한 문제가 발생할 수 있는 문제점을 가지고 있다. 이에 본 논문에서는 메타버스에서 발생할 수 있는 문제점과 그 대응 방안을 제시하였다.

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Design and Implementation of IoT Chatting Service Based on Indoor Location (실내 위치기반 사물인터넷 채팅 서비스 설계 및 구현)

  • Lee, Sunghee;Jeong, Seol Young;Kang, Soon Ju;Lee, Woo Jin
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.39C no.10
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    • pp.920-929
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    • 2014
  • Recently, embedded system which demand is explosively increasing in the fields of communication, traffic, medical and industry facilities, expands to cyber physical system (CPS) which monitors and controls the networked embedded systems. In addition, internet of things(IoT) technology using wearable devices such as Google Glass, Samsung Galaxy Gear and Sony Smart Watch are gaining attention. In this situation, Samsung Smart Home and LG Home Chat are released one after another. However, since these services can be available only between smart phones and home appliances, there is a disadvantage that information cannot be passed to other terminals without commercial global messaging server. In this paper, to solve above issues, we propose the structure of an indoor location network based on unit space, which prevents the information of the devices or each individual person from leaking to outside and can selectively communicate to all existent terminals in the network using IoT chatting. Also, it is possible to control general devices and prevent external leakage of private information.

A study on Evaluation Methods for Safety and Performance of Electrical Stimulations for Home Use (개인용전기자극기 성능 및 안전성 평가 방법 연구)

  • Kim, San;Jang, Moo-Young;Hwang, Yoon Su;Lee, Ki-Hun;Hur, Chan-Hoi;Hong, Choongman
    • Journal of the Institute of Electronics and Information Engineers
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    • v.50 no.3
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    • pp.187-202
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    • 2013
  • The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.

A Study on the Characteristics of Bad Breath in Office Workers According to Mask Selection (마스크 선택에 따른 직장인의 구취 관련 특성 연구)

  • Seo, Jeong-Cheol;Ko, Kyel;Bae, Sang-Deok;Moon, Sang-Ho;Kwon, Byong-An
    • Journal of Digital Convergence
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    • v.19 no.2
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    • pp.439-446
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    • 2021
  • This study was to investigate whether there are differences in subjective bad breath-related characteristics and psychological characteristics of sports masks printed with natural minerals compared with quarantine masks and cotton masks. The study subjects were divided into 30 people in the Sports Mask Group, 30 people in the KF Mask Group (KMG), and 30 people in the cotton mask group (CMG), and a total of 90 subjects participated in the study. It was randomly sent to use 1 mask per day and 3 masks for 3 days. The study period was conducted from October 15, 2020 to October 30, 2020. As a result of the study, there was no difference in the use of masks between the three groups in terms of bad breath health and dry mouth. However, the sports mask was superior to other masks in oral respiration and bad breath angle. As a result of analyzing psychological factors, there was no difference between the 3 groups for depression. However, in the stress factor, sports masks were superior to other masks in stress. The results of this study are valuable as suggesting the direction of use of functional masks, and we hope that they will be used as basic data for functional mask research to be studied in the future.

An Empirical Study on the Economical Competition Factors of Internet Retailers (인터넷 소매상의 경제적 경쟁요인에 관한 실증연구)

  • 이수정;남순해;고석하
    • Proceedings of the Korea Society for Industrial Systems Conference
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    • 2002.11a
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    • pp.3-13
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    • 2002
  • 고석하 등(2002)은 인터넷 소매상이 상품 품목의 명목 가격과 배송료를 이용해서 고객의 일회 총 구매 비용을 조절한다는 것을 밝혔다. 고석하 등(2002)은 같은 내용의 상품 조합을 인터넷 시장에서 구매하기 위한 비용과 전통 시장에서 구매하기 위한 비용을 비교하였다. 분석 결과, 그 교호작용과 함께, 상품 종류와 일회 구매액/가격의 크기의 두 요소가 인터넷 시장의 전통 시장에 대한 총 구매비용 할인율의 변동의 약 60%내지 80%를 설명할 수 있다는 것을 보여주었다. 한편, 구매액/가격은 인터넷 시장에서의 해당 산포도(전통 시장의 그것에 대비한)에는 거의 영향을 미치지 못하며, 상품의 종류도 산포도에는 할인율에서와 같이 큰 영향을 미치지 않았다. 인터넷 시장의 가격이나 구매비용 산포도는 상품 특성이나 구매액 크기 이외의 다른 요인에 의해서 주로 영향을 받는 것으로 나타났다. 따라서, 본 논문에서는 가격 요인 이외의 경제적 경쟁요인에 관한 실증연구로서, 2002년 6월 17일부터 20일까지, 소프트웨어, PC와 주변기기, 휴대폰, 가전제품, CD, 화장품, 그리고 책의 7가지 산업 전문 쇼핑몰과 종합 쇼핑몰을 대상으로, 인터넷 시장에서 수행되고 있는 경제적인 비 가격 경쟁요인에 관한 실증 조사를 실시하였다. 조사 결과, 인터넷 시장에서 수행되고 있는 경제적인 비 가격 경쟁요인은 매우 다양하며, 상품별로도 다른 특성을 보이고 있는 것으로 밝혀졌다. 인터넷 소매상의 경제적인 비 가격 경쟁요인은 크게 배송료 면제와 배송료 외 인센티브 제도로 구분된다 본 논문에서는 경제적인 비 가격 경쟁요인의 모든 경우의 수를 고려할 수 있도록, 코드표를 작성하여 정리하고 분석하였다.전체 분석정보의 공유가 필수적으로 발생하게 됨으로, 유전체 정보와 임상정보의 통합은 미래 의료환경에 필수기능이 될 것이다. 3) 각 생명공학 연구소에서 사용하는 첨단 분석 장비와 생명공학 정보시스템의 자동 연계가 필요하다. 현재 국내에는 전국적인 초고속정보망이 가동되어 웹을 기반으로 하는 생명정보의 공유는 기술적으로 문제가 될 수 없으나 임상정보의 유전체연구에 그리고 유전체연구정보의 임상활용은 다양한 문제를 내포하고 있다. 이에 영상을 포함한 환자정보의 유전체연구센터와 병원정보시스템과의 효율적인 연계통합 운영을 위해 국내에서는 초기 도입단계에 있는 국제적인 보건의료정보의 표준인 Health Level 7 (textural information 공유), DICOM (image 및 wave 공유), 관련 ISO표준, WHO의 ICD9/10 (질병분류), LOINC (검사 및 관련용어), SNOMED International (의학용어) 등을 활용하여야 한다.matrix. The prediction system gives about 50% of sensitivity and 98% of specificity, Based on the PID matrix, we develop a system providing several interaction information-finding services in the Internet. The system, named PreDIN (Prediction-oriented Database of Interaction Network) provides interacting domain finding services and interacting protein

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Design and Implementation of User Standing Posture Recognition-Based Interaction System Using Multi-Channel Large Area Pressure Sensors

  • Park, HyungSoo;Kim, HoonKi;Kwak, Jaekyung
    • Journal of the Korea Society of Computer and Information
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    • v.25 no.3
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    • pp.155-162
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    • 2020
  • Among the fourth industrial revolution technologies, products related to healthcare using IoT and sensors are currently being developed. We design and develop an interaction system based on user standing posture recognition using multi-channel large area pressure sensors in this paper. To this end, first of all we investigate major sensor markets of the sensor industry and review technology trends and the current and future of smart healthcare. Based on this survey, we examine and compare cases developed at home and abroad for multi-channel large-area pressure sensors, which are key components of the system that we want to develop. We recognize the standing posture status of the user through the developed system and experiment with how effective it is actually in user posture calibration and apply the research results to various healthcare devices' medical fields based on this.

Multi-channel LD - Driver designed for CTP(computer to plate) (CTP용 다 채널 LD - 드라이버 설계)

  • Lee, Bae-Kyu
    • Journal of the Korea Institute of Information and Communication Engineering
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    • v.19 no.3
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    • pp.667-673
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    • 2015
  • A laser diode(LD) has been studied in many fields what medical, industrial processing, sensor, advertising equipment, printing equipment. And the LD is being used in industry. However, LD will require precision handling. Therefore, the actual use of LD is limited to areas of specialization. In this study, attend to the characteristics of the LD what weak to electrostatic and physical impact, current and heat. And will make a sample module that use comfortably a various wavelength LD. Furthermore, Furthermore, through the printing CTP(Computer to Plate) equipment used the 128-channel LD-Driver, compares it with a 64-channel CTP device about the print speed and resolution. And will solved the problem of delay between the dot and the dot. Finally, consider the potential of the 256-channel LD-Driver.

A Study on the Effect of Patent Management Activities on Firm Outcome : The Case of Korean Product Manufacturing Firms (특허경영활동이 기업 경영성과에 미치는 영향에 관한 연구 : 국내 의료기기 제조 기업을 중심으로)

  • Kim, Yong Hyun;Jeong, Byeong Ki;Yoon, Jang Hyeok
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.39 no.1
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    • pp.1-8
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    • 2016
  • Patent management activities are considered to play a key role for technology-based firms under the recent knowledge-based economies. This is because intellectual property, including patents, can act as a system for continuous profit generation by protecting firms' products, processes and services. In Korea, healthcare industry is now regarded as one of the promising next generation industries. Despite the promise of healthcare industry, Korean healthcare product manufacturers are faced with turbulent business changes, such as market opening. Even though there are various industrial studies on the effect of patent management activities on firm outcome, previous studies have hardly paid attention to Korean healthcare product manufacturing firms. For this reason, this study identifies the effect of patent management activities, such as patenting activeness, technical excellence and cooperation degree, on firm outcomes, including financial profitability and firm growth, with respect to the Korean healthcare product manufacturers. In this study, we located 86 Korean healthcare manufacturing firms from KORCHAMBIZ and DART, and then collected the data of their patenting activities and outcomes between 2001 and 2013. By applying factor analysis and regression analysis, our empirical study found that firms' patenting activeness has the significant positive relationship on firms' financial profitability, and firms' patenting activeness and technical excellence have the significant positive relationship on firms' financial growth. Our study is an initial attempt to identify the effect of patent management activities on firm outcome within Korean healthcare product manufacturing industry, and thus its results can be used as the basis to formulate national policies for Korean healthcare product industry.