• The Korean Journal of Health Service Management
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• v.7 no.3
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• pp.203-212
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• 2013

Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

• The Journal of Economics, Marketing and Management
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• v.6 no.4
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• pp.17-27
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• 2018

Purpose - As Korea is reaching a post-aged society, the number of chronic illness is increasing, and the demand for rehabilitation medical device is growing. Although there is high potential for the growth in rehabilitation industry, because most of the related companies in Korea are relatively small, lacking capital or R&D resource, it is difficult for them to create an innovative product, and currently most of the high-tech equipments are imported. Therefore a medical device cluster, where business, research, medical institutes and universities may work cooperatively to enhance research development and solve issues is necessary for future development. Research design, data, methodology - In this method we have done a literature review of the rehabilitation industry and industrial cluster. Based on the studies, we have conducted an exploratory factor analysis by studying examples of foreign and domestic medical clusters and drawing success factors in forming a medical cluster. Next based on the studies we have conducted a survey to domestic medical device companies to find their difficulties and needs to form a successful medical device cluster. Results - This paper provides both theoretic review on success factors of forming a medical device cluster and practical analysis using case study and survey. Conclusion - The significance of this paper is that based on the literature review, we have compared actual examples of domestic/foreign medical clusters and drawn difference and coincidence between literature and actual cluster success factor. We were also able to conduct a survey on actual medical device companies and through the results we were able to search difficulties and necessities of medical device companies.

• Korean Journal of Digital Imaging in Medicine
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• v.10 no.2
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• pp.33-37
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• 2008

To keep the online medical records available to anyone without constraint of time and space, introducing EMR (Electronic medical record), which is a clinical support management system. The purpose of this study is to develop interface standard of clinical test device. Integration and sharing of medical information is faced with enormous obstacles because medical organizations and associated companies are separately developing the interface. I hope that multi-function management system with workstation concept is operated to efficiently transmit clinical device result data based on this study. Transfer of precise medical result data available for decision making will improve quality of health care service.

• Convergence Security Journal
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• v.21 no.1
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• pp.63-72
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• 2021

The hospital biomedical engineering team is responsible for establishing and regulating the Medical Device Management Program (MEMP) to ensure that medical devices are safe and reliable. As technology advances, medical devices such as artificial intelligence and precision medicine are developing into a form that allows connection between objects anytime, anywhere, and as various technologies converge, internal and external security threats continue to increase. In this paper, we present a study of the Medical Device Management Program (Secure-MEMP) method, considering that the security threat of medical devices continues to increase due to advances in technology.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.11 no.4
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• pp.299-306
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• 2017

The Korean medical device industry has increased dramatically due to various investments in the domestic medical device industry and the introduction of new technologies, but the domestic medical device usage rate in great hospital is still low. In this paper, improvement point for domestic medical device was suggested by domestic medical device usage rate and user and manager's perception survey in great hospitals in Korea. To do this, a survey on the types of medical devices and domestic medical device usage rates were conducted at four national university hospitals in Korea. From this results, the priority survey medical devices were selected. Improvements of Korean medical devices were suggested by failure mode analysis and user awareness surveys for the priority survey medical devices.

• Journal of Biomedical Engineering Research
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• v.39 no.6
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• pp.268-277
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• 2018

With drastic change in the market and technology of medical devices, a comparative analysis is necessary in advanced systems internationally in order to prepare domestically applicable plans for improvement in classification and differential grade management for items of medical devices. This research examines and analyzes the differences of definition and legal systems of medical devices among Korea, United States, EU, Japan and China, and investigates classification and grading system of each country to identify disadvantages of classification and grading structures for medical device in Korea. This research suggests ways to supplement the disadvantages of domestic classification and grading system of medical devices, and elicits differential management plans for medical devices.

• Proceedings of the Korea Information Processing Society Conference
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• 2006.11a
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• pp.571-574
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• 2006

2006년 5월 국제전기기술위원회(International Electrotechnical Commission, IEC) TC62(의료용전기기기기술위원회) SC62A(의료용전기기기 공통특성에 관한 세부분과위원회)에서 의료기기 소프트웨어의 생명주기 프로세스에 관한 국제규격인 IEC 62304, Ed.1을 제정하였다. 전체 내용은 크게 일반적인 요구사항(General requirements)과 소프트웨어 개발과 유지보수에 대한 프로세스(Software development & maintenance process)로 구성되어 있다. 그리고 소프트웨어 개발과 유지보수 프로세스가 진행되는 동안에 기본적으로 확보되어야 하는 소프트웨어 위험관리와 형상관리에 대한 프로세스 Software risk management & configuration management process)를 규정하고, 또한 문제 발생 시 이를 해결하기 위한 소프트웨어 문제 해결 프로세스(Software problem resolution process)를 규정하고 있다. 이는 기존의 정보통신 분야에서 사용되던 소프트웨어 생명주기 프로세스인 ISO/IEC 12207 규격과 외형상 많은 차이를 나타내고 있다. 이에 본 논문에서는 의료기기 소프트웨어의 생명주기 프로세스에 관한 국제규격인 IEC 652304를 분석하여 실제 의료용 소프트웨어 개발 및 유지보수 작업들이 어떠한 방식으로 이루어지는지를 분석하고, 또한 기존의 소프트웨어 생명주기 프로세스인 ISO/IEC 12207 규격과의 차이점을 비교 분석하여 본 규격에 대한 근본적인 활용 방안을 모색하고자 한다.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.6
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• pp.382-390
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• 2018

This study developed a model to evaluate the quality management system of a medical device manufacturing company, and applied it to medical device manufacturers to understand the impact on business performance in response to international regulations and industry's change. This study prepared preliminary items, defined four (4) major factors (Plan-Do-Check-Act) that consist of the evaluation layers and items per category according to prior research review and expert interview, and calculated the weight and importance using AHP. The study results showed that responsibility & authority and quality objective in Planning Category, product-related requirement and R&D in Doing Category, Measuring and monitoring in Check Category, and review of meeting Regulatory and regulation in Action Category are relatively more important factors. The evaluation model developed based on the calculated weight and importance to business performance was applied to medical device manufacturers to investigate and analyze the implementation level of QMS and its impact on business performance according to each category. Most medical device manufacturers to be studied showed a reasonable level of QMS and effective business performance. Almost all the evaluation layers and items in the four (4) factors had a significant influence on business performance. Although the medical device quality management system is aimed mainly at license acquisition, it is important that management environment factors not related directly to licensing and authorization are important to business performance, and it is effective when these factors are integrated and operated within and outside the manufacturer.

• 한국노년학
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• v.30 no.3
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• pp.803-814
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• 2010

This study was conducted to understand current management status of welfare medical device centers and to suggest complementary point. Method: We surveyed 194 welfare medical device centers through the mail. The survey was done in three domains, i. e. management of service, assuring the health resources, offering the service. Results & Conclusions: According to the result of our study, several problems, which should be improved in the near future, were suggested. That were improving facilities(especially in sanitization of the devices), operating an education or training program for the personnel, and making up for the current management. It was very important for soft landing of long-term care insurance and improving quality of the elderly's life that 'Ministry of Health and Welfare' and 'National Health Insurance corporation' must support welfare medical device centers for discharging their roles

• The Journal of the Korean dental association
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• v.56 no.9
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• pp.479-490
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• 2018

3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.