• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.29-37
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• 2022

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

• The Korean Journal of Emergency Medical Services
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• v.26 no.1
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• pp.87-99
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• 2022

Purpose: This study aimed to provide basic data for the improvement of the standards related to the performance improvement of the firefighting equipment standards for special ambulances. Methods: Among the domestic firefighting equipment standards, the special ambulance standard was compared with the NFPA 1917 standard for the United States automobile ambulance 2019 and European Union European standard EN 1789 medical vehicle and its equipment, a road ambulance. Results: Anti-skid performance based on indoor noise standards, performance standards for interior lights, seat belt warning device, child car seat fixing device, safety handle, auxiliary footrest, and flooring materials should be supplemented. Conclusion: It is necessary to strengthen the production and performance standards for improvement to a level corresponding to the national standards, such as the United States and European Union.

• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.7 no.1
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• pp.67-72
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• 2012

This study describes the environment change of an internal and external medical device market to be entered to European market of an urinary incontinence treatment device, is aimed at suggesting a participation plan analyzing urinary incontinence and treatments, and characteristic of new products & European urinary incontinence market. In conclusion, to sell the urinary incontinence treatment device developed as the world's first in European market, the following strategies are needed. First, the strategies domestic firms make family doctors and urologists heighten awareness of the urinary incontinence treatment device developed in Korea through participation of associations and exhibition being held in Europe to increase a market penetration level are needed. Second, it may be necessary to emphasize the fact that this devices are a characterful products and treatments, and cost-effectiveness treatments reducing infection ratio. Third, the domestic production firms of the urinary incontinence treatment device should suggest quality, delivery, and price consistency through looking for ways to lower the price while maintaining the quality in an increasingly competitive market conditions.

• 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.

• 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.

• The Journal of the Convergence on Culture Technology
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• v.9 no.2
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• pp.525-531
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• 2023

In Korea, which is entering a super-aged society, the number of elderly patients who have difficulty walking independently is expected to increase rapidly, and it is necessary to develop wheelchair products with various functions to improve the quality of life of people with walking disabilities. Recently, wheelchair power assist devices that provide propulsion power by being attached to a manual wheelchair has been developed and is entering the domestic and global markets. In this study, we compared and analyzed the process of obtaining medical device certification for wheelchair power assist devices in Korea, the United States, and Europe. In Korea, a Class 2 medical device certification process was developed in 2021, and in the US FDA, it corresponds to Class 2 like the existing electric wheelchair and must pass the 510k certification process. In the case of Europe, it is uniquely regulated as Class I, and the CE mark can be attached through a relatively easy self-declaration of conformity. The Korean medical device industry, which is struggling with MDR certification, a new European medical device regulation, should pay attention to the relatively easy entry into the global market for wheelchair power assist products.

• Clinical and Experimental Pediatrics
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• v.54 no.11
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• pp.463-469
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• 2011

Purpose: To validate the Dinamap ProCare 200 blood pressure (BP) monitor against a mercury sphygmomanometer in children 7 to 18 years old in accordance with the 2010 International Protocol of European Society of Hypertension (ESH-IP2) and the British Hypertension Society (BHS) protocol. Methods: Forty-five children were recruited for the study. A validation procedure was performed following the protocol based on the ESH-IP2 and BHS protocols for children and adolescents. Each subject underwent 7 sequential BP measurements alternatively with a mercury sphygmomanometer and the test device by trained nurses. The results were analyzed according to the validation criteria of ESH-IP2. Results: The mean (${\pm}SD$) difference in the absolute BP values between test device and mercury sphygmomanometer readings was $1.85{\pm}1.65$ mmHg for systolic BP (SBP) and $4.41{\pm}3.53$ mmHg for diastolic BP (DBP). These results fulfilled the Association for the Advancement of Medical Instrumentation criterion of a mean${\pm}$SD below $5{\pm}8$ mmHg for both SBP and DBP. The percentages of test device-observer mercury sphygmomanometer BP differences within 5, 10, and 15 mmHg were 96%, 100%, and 100% for SBP, and 69%, 92%, and 100% for DBP, respectively, in the part 1 analysis; both SBP and DBP passed the part 1 criteria. In the part 2 analysis, SBP passed the criteria but DBP failed. Conclusion: Although the Dinamap ProCare 200 BP monitor failed an adapted ESH-IP2, SBP passed. When comparing BP readings measured by oscillometers and mercury sphygmomanometers, one has to consider the differences between them, particularly in DBP, because DBP can be underestimated.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.22 no.3
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• pp.133-138
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• 2022

Digital radiation inspection equipment is a medical device that deals with human life and requires stability and high reliability. However, this system is currently the most advanced technology and the domestic market is almost occupied by European products including Japan. Therefore, research and development are needed not only to replace domestic medical devices, which are largely dependent on expensive imported products, but also to develop more economical and user-oriented products that are easy to operate and produce devices that lead to accurate diagnosis. In particular, among the digital X-ray systems, the motor driving technology and the mechatronics technology related to the development of mechanical devices have matured to some extent in Korea. In this paper, selection of AC servomotor for digital radiation inspection suitable for imaging purpose, and application of conversion device and control method to check performance and improve problems.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.21 no.4
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• pp.129-134
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• 2021

A power tool is a tool used to manufacture and process various structures using a motor that is a power source. Using a motor that uses electricity as a power source, a reduction device, power transmission and conversion device functions are built-in to make the tool rotate, reciprocate, and vibrate. It is a work tool designed to assist the user's movement skills. In the case of Korea, the power tool industry has a short history and is lagging behind advanced countries such as Germany, the United States, and Japan in terms of technology level, market share, and recognition. In addition, electric drivers used in Korea are foreign products from the US and European countries, and the domestic market also prefers 100% foreign companies, and multinational companies are investing a lot in the domestic market. Therefore, technological development must follow in order to develop domestic technology and secure a consistently high market share. The purpose of this thesis is to design a motor driver with high output performance of motor performance, miniaturization, and high speed in accordance with the basic performance requirements of power tools, and finally research developments that can be applied to industrial and medical applications.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.