• 대한예방한의학회지
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• 제28권1호
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• 보건의료산업학회지
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• 제7권3호
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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.

• 대한영상의학회지
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• 제85권4호
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• pp.693-704
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• 2024

흉부 X선은 인공지능 기술이 활발히 적용되고 있는 대표적인 영상 검사이다. 흉부 X선 영상에서 다양한 이상 소견을 자동으로 검출하여 의사의 판독을 보조하는 인공지능 기반 소프트웨어 의료기기들이 국내에서 시판되고 있고, 임상 적용이 활발히 이루어지고 있다. 이러한 흉부 X선 인공지능 검출 보조 의료기기의 임상 도입에 있어, 도입 전 성능 및 유효성 평가, 적용 대상, 분석 결과 제공의 대상 및 방식, 도입 후 모니터링, 법적 책임 문제 등 다양한 현실적인 사항에 대한 고려가 필요하고, 각 의료기관의 상황에 따른 적절한 의사결정이 필요하다. 인공지능 검출 보조 의료기기의 안전하고 효율적인 도입 및 운영을 위해서는 전문 지식을 갖춘 영상의학과 전문의의 적극적인 역할이 필수적이다.

• 정보처리학회논문지D
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• 제13D권2호
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• pp.259-270
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• 2006

의료기기 내장형 소프트웨어는 인간의 생명과 직결되는 의료기기를 제어하는 소프트웨어이기 때문에 높은 품질 수준을 요구한다. 의료기기 내장형 소프트웨어의 높은 품질 요구를 만족시키기 위해서는 그 요구사항에 적합한 품질시험 모듈을 개발하여 적용하고 결과를 피드백하여 소프트웨어의 품질 결함을 보완하는 과정이 필요하다. 본 연구에서는 ISO/IEC 12119를 기반으로 의료기기 내장형 소프트웨어를 시험하여 결과를 산출할 수 있는 시험모듈과 품질검사표를 개발하여 의료용 소프트웨어 시험에 적용할 수 있도록 하였다.

• 대한의사협회지
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• 제61권12호
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• pp.765-775
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• 2018

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

• 한국의학물리학회지:의학물리
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• 제8권2호
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• pp.59-65
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• 1997

전자포탈영상장치 (EPID)를 이용하여 의료용 선형가속기의 기하학적인 요소를 성능 평가할 수 있도록 고안하였다. light field와 radiation field 의 일치, 콜리메이터 회전축, 갠트리 회전축 크기 등을 측정하였다. EPID에서 수집한 영상정보를 이용하여 radiation-light field 일치여 부를 1mm 이내의 정밀도를 갖고 평가하였으며, 콜리메이터, 갠트리 회전축 역시 4개의 방사선 방향에 대한 영상을 중첩시켜서 중첩된 영상이 이루는 교점을 분석하여 구할 수 있었다. 이 방법으로 선형가속기의 기하학적인 QC/QA를 객관적이고 정량적으로 시행할 수 있었다.

• International Journal of Computer Science & Network Security
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• 제22권6호
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• pp.63-66
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• 2022

The article discusses the application of the IoT concept in the sensitive field of medical devices on the example of a developed prototype of a mechanotherapeutic simulator. Mechanotherapy is a complex of therapeutic, preventive, and restorative exercises conducted using simulators, specially designed for developing movements in individual joints. Mechanotherapy is used for the early and painless restoration of joint mobility, to prevent complications associated with prolonged immobilization of the injured area of extremities. Using the mechanotherapy simulator allows developing the joint painlessly, which accelerates the metabolism in the injured area, and soft tissues are restored to normal. The article provides information about the electronic components that ensure the wireless operation of the device and describes in detail the applied software as well as the client application for a mobile device.

• 대한의용생체공학회:의공학회지
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• 제8권2호
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• pp.118-122
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• 1987

The medical image processing system is intended for a diverse set of users in the medical Imaging Parts. This system consists of a 640 Kbyte IBM-PC/AT with 30 Mbyte hard disk, special purpose image processor with video input devices and display monitor. Image may be recorded and processed in real time at sampling rate up to 10 MHz. This system provides a wide range of image enhancement processing facilities via a menu-driven software packages. These facilities include point by point processing, image averaging, convolution filter and subtraction.

• 정보과학회 논문지
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• 제42권12호
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• pp.1590-1599
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• 2015

다양한 개인 의료 장비들이 등장함에 따라 개인 의료 컨텍스트가 풍부하게 수집되고 있다. 이렇게 수집된 의료 컨텍스트를 분석함으로써 소프트웨어적으로 질병을 진단하기 위한 노력이 이어지고 있다. 본 논문에서는 의료 전문가들이 사용하는 의료 분석 기법을 정형화하고, 각 의료 기법을 실현화하기 위한 추론 기법을 식별하며, 추론기법의 적용 지침을 제시한다. 또한, 의료 기법을 제공하는 추론 시스템을 PoC 수준에서 개발하고, 실제 의료 컨텍스트를 분석하여 질병 진단 실험을 수행함으로써 제시하는 의료 분석 기법 및 추론 기법 적용 지침의 실효성과 그 효과를 검증한다.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.