• Journal of Biomedical Engineering Research
• /
• v.44 no.1
• /
• pp.73-79
• /
• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• Journal of Biomedical Engineering Research
• /
• v.40 no.1
• /
• pp.20-31
• /
• 2019

Medical device performance management is an activity that allows a device to be safely used and maintained even after it is put on the market. The purpose of this study is to provide procedures and criteria for selection of medical device items that should manage the safety and performance among medical devices in hospital. Investigate the performance management status of medical devices in hospitals and identify the performance management status by domestic and advanced regulatory agencies. Provides selection procedures and test methods for medical devices subject to performance management in hospitals based on medical device risk management and reliability. In addition, a case study on drug infusion pumps was conducted.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
• /
• 2012.10a
• /
• pp.495-497
• /
• 2012

Development of application risk management for medical device software test. First, Through questionnaires, Medical device manufacturers, Analysis of software validation and risk management status. Second, Analyzed by comparing the difference between black box testing and white box testing. Third, After analyzing the potential for software analysis tools using code derived factors were quantified, Finally, Medical device risk management process so that it can be applied to build the framework by FMEA(Failure Mode and Effect Analysis) technique. Through this Difficult to build software validation and risk management processes for manufacturers to take advantage of support in medical device GMP(Good Manufacture Practice).

• Journal of Biomedical Engineering Research
• /
• v.44 no.1
• /
• pp.41-52
• /
• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.

• Journal of Biomedical Engineering Research
• /
• v.44 no.1
• /
• pp.1-10
• /
• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Journal of Biomedical Engineering Research
• /
• v.44 no.2
• /
• pp.99-108
• /
• 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.

• Journal of Biomedical Engineering Research
• /
• v.44 no.5
• /
• pp.315-323
• /
• 2023

The objective of this study is to identify the selective application targets for reporting on details of supply of class 1 and 2 medical devices as part of the improvement of the reports on details of supply of medical device system, and to analyze its effectiveness. Therapeutic materials covered by health insurance and secondhand medical devices were chosen based on the transparency of health insurance coverage and the management of medical device distribution. As a result, approximately 85% of groups can be excluded from the reporting requirements compared to reporting all items under Class 1 and 2 medical devices. This is expected to enhance the efficiency of supply reporting tasks. Additionally, the information on supply details managed by the regulatory authority can be utilized for statistical analysis and periodic monitoring, serving as fundamental data for the development of medical device-related policies and research in the field of medical devices.

• Journal of Korean Society for Quality Management
• /
• v.50 no.3
• /
• pp.503-515
• /
• 2022

Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

• Journal of Biomedical Engineering Research
• /
• v.44 no.1
• /
• pp.19-24
• /
• 2023

Due to the spread of COVID-19, many patients with severe respiratory diseases have occurred worldwide, and accordingly, the use of mechanical ventilators has exploded. However, hospitals do not have systematic risk management, and the Medical Device Regulation also provides medical device risk management standards for manufacturers, but does not apply to devices in use. In this paper, we applied the Failure Mode Effects Analysis (FMEA) risk analysis technique based on the International Standard ISO 14971 (Medical Devices-Application of risk management to medical devices) for 85 mechanical ventilators of a specific model in use in hospitals. Failure modes and effects of each parts were investigated, and risk priority was derived through multiplication of each score by preparing criteria for severity, occurrence, and detection for each failure mode. As a result, it was confirmed that the microprocessor-based Patient Unit/Monitoring board in charge of monitoring scored the highest score with 36 points, and that reliability management is possible through systematic risk management according to priority.

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