• Journal of Information Technology Services
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• v.22 no.4
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• pp.21-35
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• 2023

Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.8 no.4
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• pp.758-767
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• 2007

Today, medical devices is making great progress in type of the electronic medical device controlled by embedded software. So, the quality of electronic medical devices is dependant on the quality of embedded medical software. Especially, considering that medical devices closely connected to human life, we think the study about reliability of medical devices will be needed in the quality of programmable electronic medical devices. In this thesis, we constructed the reliability evaluation method based on ISO/IEC 9126 and ISO/IEC 12119, and developed the system that can applicate FMEA method, the one of the reliability evaluation method.

• Journal of Dental Rehabilitation and Applied Science
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• v.36 no.4
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• pp.203-210
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• 2020

By facing the era of the 4th industrial revolution, personalized medical services for patients are expanding with the development of information and communications technology. With these changes, digital medical devices have begun to be used to support diagnosis, patient monitoring, and decision-making of diseases, and recently software medical devices for the purpose of preventing, managing, or treating disorders or diseases have become popular. The aim of this article is to understand the current concept and status of Software as a Medical Device (SaMD), which are actively being carried out in the United States, and to find out what fields can be applied in the future. In addition, it intends to find out the Korean domestic policy trends related to smart healthcare and find out the application of digital software as a medical devices that can be used in dental clinic to keep pace with the upcoming changes in the medical field.

• The Transactions of the Korean Institute of Electrical Engineers P
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• v.64 no.3
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• pp.175-181
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• 2015

In this paper, the neuromuscular electrical stimulation medical devices for non-implantable incontinence treatment other than vaginal insertion type was developed and commercialized. The structure of medical devices for electrical stimulation based on the anatomy of the pelvic floor muscle designed. Then, the optimum parameters that may be effective in pelvic floor muscle electrical stimulation was set. The circuit system based on the optimum parameters were designed and manufactured. The frequency of the pulse voltage for electrical stimulation is 75[Hz], the pulse width is 300[${\mu}s$], the development of medical devices was to have seven program functions to the various treatments. The circuit system of medical devices was composed of microcontroller, comparator and converter. The performance of the developed circuit system in KTC(Korea Testing Certification) were carried out medical equipment inspection test. Test results, test specifications were satisfied with the medical device, the performance was verified to be commercialized as a medical device. The development of medical devices were validated risk assessment and product performance through a software validation. Commercialization of medical equipment was acquired to enable the certification standards of the international standard IEC 60601-1.

• IEMEK Journal of Embedded Systems and Applications
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• v.16 no.6
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• pp.313-321
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• 2021

The global market for medical devices is huge, and it will continue showing remarkable growth in the future. However, due to the entry barrier to develop medical devices, many domestic companies have technical problems in entering the medical device industry. In this paper, we introduce an open platform that can help with research and development for companies in the healthcare industry. This open platform consists of a hardware part and a software part. A hardware part is combined into CPU, base and other modules that are easy to replace and assemble. A software part is based on application software for development developed by Bionet. We test the performance of the open medical device platform using a biosignal processing algorithm.

• The KIPS Transactions:PartD
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• v.10D no.5
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• pp.781-792
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• 2003

We medical software is becoming important means to secure competitive power of medical service by explosive increase of medical device based on software, and the quality of medical service is affected to quality of medical software as well as medical devices. But domestic related study and development is not sufficient for quality of medical software, and a falling-off in medical software quality can induce a falling-off in quality of medical service. Therefore, it is necessary to raise qualitative level of medical service by progress and quality improvement of medical devices. Therefore, in this paper, we developed test module and qualify inspection table which can test medical software and produce result based on ISO/1EC 12119.

• IEMEK Journal of Embedded Systems and Applications
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• v.7 no.5
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• pp.219-226
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• 2012

The rises of the life index quality together with the medical technology improvement lead to a longer life expectancy. Then a better health care program, especially for elderly, is needed. The common health problems facing those senior citizens are changed from acute diseases to chronic diseases, such as diabetes, hypertension. Then u-Health takes center stage in medical industry. Although u- Health medical device manufacturers have been improving their instruments, these instruments still rely on proprietary technologies without fixed platform. Even if the interface has been provided by the manufacturer, there is no widely-accepted uniform data model to access data of various u-Health devices. IEEE 11073 is a standard attempting to unify the interfaces of all medical devices. In this paper we have proposed a conversion software platform that assures interoperability among medical devices for ubiquitous sensor network. This module uses in order to develop a standard platform of medical system.

• Journal of Biomedical Engineering Research
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• v.44 no.4
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• pp.264-274
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• 2023

Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.

• KIPS Transactions on Software and Data Engineering
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• v.6 no.12
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• pp.543-548
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• 2017

In recent years, the importance of the safety of medical device software has been emphasized because of the function and role of the software among components of the medical device, and because the operation of the medical device software is directly related to the life and safety of the user. To this end, various standards have been set up that provide activities that can effectively ensure the safety of medical devices and provide their respective requirements. The activities that standards provide to ensure the safety of medical device software are largely divided into the development life cycle of medical device software and the risk management process. These two activities should be concurrent with the development process, but there is a limitation that the risk management requirements to be performed at each stage of the medical device software development life cycle are not classified. As a result, developers must analyze the association of standards directly to develop risk management activities during the development of medical devices. Therefore, in this paper, we analyze the relationship between medical device software development life cycle and risk management process, and extract risk management requirement items. It enables efficient and systematic risk management during the development of medical device software by mapping the extracted risk management requirement items to the development life cycle based on the analyzed associations.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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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.