• 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.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.17 no.1
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• pp.49-56
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• 2013

Among U-healthcare services adapting the latest IT technique and medical technique, a body-injecting device technique providing medical service to a patient who has incurable disease. But the body-injecting device technique can be easily exposed during wireless section to the third person and it can be used illegally. This paper proposes certification protocol which certifies a patient and hospital staff using random number created by certification server and a patient with hospital staff by synchronization. Specially, the proposed protocol uses security information created by information registered in certification server previously by a patient and hospital staff so that in keeps from accessing of third person who didn't get approval. And it gives more stability.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.41 no.1
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• pp.11-23
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• 2018

This paper investigated relationship among internal as well as external motive to receive the ISO 13485 certification, countermeasure to the certification examination, active reception/execution level of the certification, and operational as well as financial performance of the medical device related enterprises in South Korea which received and are maintaining the ISO 13485 certification. SEM (structural equation model) and related analyses using AMOS 21.0 and SPSS 21.0 have been applied to verify the hypotheses of the research. Result of the research showed that internal as well as external motive for certification positively(+) affects active reception/execution level of the certification as well as countermeasure to the certification examination. The reception/execution level of the certification also positively(+) affects on the operational as well as financial performance of the certified enterprises. However, countermeasure to the certification examination was found out to negatively(-) affects the active reception/execution level of the certification and we can interpret that relatively more countermeasure to the certification examination burdens the employees of the enterprise, causing them to be less active on the reception/execution level of the certification. This research found that an enterprise's operational/financial performance improves when an enterprise introduces the ISO 13485 certification standard spontaneously on the purpose of improving its system and the certification system is applied to the enterprise actively, not passively. This research emphasizes the need to recognize the difference of the level of active reception implication among members of an enterprise according to the motive of introduction of the certification system.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.45
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• pp.191-238
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• 2010

The purpose of this paper is to make research on the trend of the worldwide medical device market, the trend of the medical device market in the major foreign countries, the present status of the medical device industry in Korea and Gangwon area, the present status of export competitive power and the SWOT analysis of competitive power of the medical device industry in Gangwon area, and the strengthening methods of export competitive power of the medical device industry in Gangwon area. As the research method, the questionaire for the strengthening of export competitive power of the medical device industry in Gangwon area was carried out from August 13 to Otober 22, 2009. The worldwide medical device market in 2008 is estimated at USD 210.2 billion, with the United States being the largest market, followed closely by Japan and Western Europe. In 2006, the worldwide export amount of medical devices recorded USD 121.1 billion and the worldwide import amount of medical devices recorded USD 126.3 billion. As of the end of 2008, the number of Korea's medical device manufacturers expanded to 1,726. The production amount of Korea's medical device industry in 2008 recorded 2,525 billion won, and the domestic market volume of medical devices in 2008 recorded 3,618 billion won. Korea's export amount of medical devices in 2008 recorded USD 1,132 million and recorded a 9.67% growth compared to the previous year, and the import amount of medical devices recorded USD 2,123 million and recorded a 1.43% reduction compared to the previous year. As of the end of 2008, the number of Gangwon area's medical device manufacturers expanded to 81. The production amount of Gangwon area's medical industry in 2008 recorded 380 billion won, and Gangwon area's export amount of medical devices recorded USD 269 million and recorded a 0.25% reduction compared to the previous year, and the import amount of medical devices recorded USD 3 million and recorded a 39.63% reduction compared to the previous year. According to the result analysis of the questionaire for the strengthening of export competitive power of medical device industry in Gangwon area(August 13~October 22, 2009), the competing country of the export medical device is the United States being the highest ranking. Comparing to the collective competitive power level 100 of the competing country, the collective competitive level of the export medical device is 60 below and 70-80 below being the highest ranking. Comparing to the quality level 100 of the United States, EU and Japan, the quality level of the export medical device is 80-90 below being the highest ranking. Comparing to the design level 100 of the United States, EU and Japan, the design level of the export medical device is 90-100 below being the highest ranking. Comparing to the technology level 100 of the United States, EU and Japan, the technology level of the export medical device is 80-90 below being the highest ranking. According to the SWOT analysis of competitive power of medical device industry in Gangwon area, the strength is the abundant expert manpower of the medical device in Wonju area. The weakness is the fragility of the brand recognition of the medical device industry. The opportunity is the demand increase of the new medical device owing to the advanced age of population. The threat is the difficulty of entry into overseas market owing to the request of the new specification certification of the medical device. In order to strengthen the export competitive power of the medical device industry in Gangwon area, the following measures should be taken by the government, local self-government body, related organization and medical device industry : the development of new technology and design, the enhancement of brand recognition. the acquisition of the foreign specification certification, the building of overseas distribution channel and after sales service channel, the positive participation in overseas medical device exhibition and opening of medical device exhibition, the training of expert manpower, the strengthening of overseas marketing, and the application of FTA and the establishment of counter measures against FTA. In conclusion, the medical device industry in Gangwon area has the difficulty in the entry into the overseas market owing to the shortage of overseas marketing capability. Therefore, the government and local self-government body should make the intensive and systematical support for overseas marketing of the medical device industry. For the support of overseas marketing, the government and local self-government body should provide positively the support of expenses for the acquisition of foreign specification certification, the support of participation in the overseas medical device exhibition, the despatch of market development mission, the increase of the support amount for R&D investment fund, and the training of expert manpower of medical devices.

• 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.

• Journal of Biomedical Engineering Research
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• v.42 no.1
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• pp.7-17
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• 2021

In the case of domestic medical device advertisements, it is possible to proceed with the advertisement after medical device certification, and pre-deliberation is possible based on the medical device technical document. However, there are some medical device advertisements that stakeholders in administrative procedures have no choice but to misunderstand in customs and laws that do not consider users. In addition, medical equipment and the pre-deliberation system were judged to be unconstitutional, and unconstitutional decisions were made in accordance with the principle of prohibiting pre-censorship based on the Constitution. This is because in domestic medical device advertisements, structural contradictions and user damage occur in the central structure of each stakeholder. It is necessary to reestablish stakeholder relationships, increase water solubility from customs and laws, and seek new policy proposals. In this study, we reestablish relationships with stakeholders by applying the Autopoiesis theory, and present the grounds and directions that can prevent hype and misidentified advertisements through the establishment of user-centered policies, and the measures to be taken by the Constitutional Court unconstitutional decision.

• 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.

• Korean Journal of Veterinary Research
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• v.57 no.2
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• pp.71-78
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• 2017

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

• Journal of Biomedical Engineering Research
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• v.38 no.3
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• pp.89-94
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• 2017

In order to improve national competitiveness through technological research and development, the government puts in R&D budget every year and manages to improve the R&D results. Accordingly, various R&D project management methods have applied for successful advancement of technology and product. TRL is a measurement system developed by NASA to assess the maturity of technology since the 1970s. To apply medical device, the characteristics such as regulation, clinical trials are considered as a significant influence. In this study, we would like to derive PMI(performance measures index) for medical device R&D projects by using TRL and stage-gate model. As a result of this study, it is possible to use the PMI for decision making and evaluation in the R&D projects and believed that the objectivity can be ensured by the approval or certification of regulatory authority.

• Journal of the Microelectronics and Packaging Society
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• v.23 no.4
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• pp.11-18
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• 2016

Today, wearable technology products are used in a wide range of consumer, healthcare, bio-medical, and industrial applications. The market for wearable technology products is expected to increase dramatically over the next several years. In addition, concerns for safety, performance and reliability of wearable products keep increasing and will be essential for widespread acceptance in the marketplace. Wearable smart devices, which are generally in contact with the human body and skin, are exposed to the risk of the electric shock, burn, and explosion. Therefore, the standardization of wearable devices in terms of human safety and reliability should be very important. Furthermore, the development of test method and test certification of the wearable products will be one of the key technology for mass production. Such standardization and certification will help consumers to choose the safest and best quality wearable devices and allow manufacturers to prove the safety and quality of their products, thereby helping them to gain a competitive technology. This paper discusses the current status of the wearable smart devices as well as the standardization and test certification applicable to wearable technology products.