• Journal of the Korean Society of Safety
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• v.27 no.2
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• pp.92-97
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• 2012

Risk management is the process that helps to identify hazards, analyze them, and then to create an action plan to avoid and mitigate these hazards. The main objective of risk management in product development and manufacturing is to provide safe and efficient products without spending too many resources. Medical device manufacturers also face enormous risks - regulatory, legal, and financial - based on their products and processes, and the concepts of risk management are particularly important because any single failure may result in serious damages to body or loss of life. In this regard, a set of guidelines for the application of risk management to medical devices has been issued by ISO and specified in the document ISO 14971 Medical devices - Application of risk management to medical devices. The main objective of this study is to investigate the application of risk management to dental implant development and manufacturing processes based on ISO 14971. A general risk management process is first introduced, and the application of ISO 14971 to dental implants is further investigated.

• 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.

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

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 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 Korean Society for Quality Management
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• v.46 no.2
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• pp.211-224
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• 2018

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

• Proceedings of the Safety Management and Science Conference
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• 2006.04a
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• pp.513-523
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• 2006

This paper is to introduce guidelines for risk management and analysis. International tandards such as IEC 60300-3-9, IEC 61511-3, ISO 14971-1 and ISO/IEC Guide 73 are considered. This study is to discuss risk analysis of technological systems, and guidelines in the application of hazard and risk analysis for functional safety instrumented system, and risk management of medical devices, and guidelines for use in risk management standards.

• Proceedings of the Korean Reliability Society Conference
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• 2002.06a
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• pp.321-328
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• 2002

다양한 리스크문제가 발생하고 있는 기업 환경 속에서 세계선도 기업들은 이미 효과적인 리스크 관리시스템의 운영을 통하여 기업의 손실을 최소화함으로써 이윤을 극대화하고 있으나 우리 기업들은 아직 그렇지 못한 실정이다. 본 연구에서는 국제규격인 ISO14971과 IEC62198, JIS Q 2001의 리스크 경영 규격을 중심으로 리스크 경영 시스템(Risk Management System : RMS)의 구성을 분석 비교한다. 각각의 규격에서 사용되는 적용범위, 용어 및 정의, 리스크 경영의 개념과 절차, 경영 시스템에 적용되는 기법들을 비교, 분석하여 우리 기업들이 가지고 있는 리스크문제를 효과적으로 관리할 수 있는 대안 모색을 가능하도록 하는 기초 자료를 제시하고자 한다.

• Journal of Multimedia Information System
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• v.2 no.2
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• pp.241-248
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• 2015

The safety-critical software in healthcare systems needs more and more perceptive excess among human observation and computer support. It is a challenging conversion that we are fronting in confirming security in healthcare systems. Held in the center are the patients-the most important receivers of care. Patient injuries and fatalities connected to health information technologies commonly show up in the news, contrasted with tales of how health experts are being provided financial motivation to approve the products that may be generating damage. Those events are unbelievable and terrifying, however they emphasize on a crucial issue and understanding that we have to be more careful for the safety and protection of our patients.

• Proceedings of the Korean Operations and Management Science Society Conference
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• 2002.05a
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• pp.797-803
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• 2002

다양한 리스크 문제가 발생하고 있는 기업 환경 속에서 세계선도 기업들은 이미 효과적인 리스크 관리시스템의 운영을 통하여 개업의 손실을 최소화함으로써 이윤을 극대화하고 있으나 우리 기업들은 아직 그렇지 못한 실정이다. 본 연구에서는 국제규격인 ISO14971과 IEC62198, JIS Q2001의 리스크 경영 규격을 중심으로 리스크 경영 시스템(Risk Management System :RMS)의 구성을 분석 비교한다. 각각의 규격에서 사용되는 적용범위, 용어 및 정의 리스크 경영의 개념과 절차, 경영 시스템에 적용되는 기법들을 비교, 분석하여 우리 기업들이 가지고있는 리스크 문제를 효과적으로 관리할 수 있는 대안 모색을 가능하도록 하는 기초 자료를 제시하고자 한다.

• Korean Journal of Digital Imaging in Medicine
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• v.11 no.2
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• pp.69-77
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• 2009

This study gives an account of the collateral standards in IEC 60601-1-3: 2008 specifying the general requirements for basic safety and essential performance of diagnostic X-ray equipment regarding radiation protection as it pertains to the production of X-rays. The collateral standards establish general requirements for safety regarding ionization radiation in diagnostic radiation systems and describe a verifiable evaluation method of suitable requirements regarding control over the lowest possible dose equivalent for patients, radiologic technologists, and others. The particular standards for each equipment can be determined by the general requirements in the collateral standard and the particular standard is followed in the risk management file. The guidelines for radiation safety of diagnostic radiation systems is written up in ISO 13485, ISO 14971, IEC 60601-1-3(2002)1st edition, medical electric equipment part 1-3, and the general requirements for safety-collateral standards: programmable electrical medical systems. Therefore the diagnostic radiation system protects citizens' health rights with the establishment and revisions of laws and standards for diagnostic radiation systems as a background for the general requirements of radiation safe guards applies, as an international trend, standards regarding the medical radiation safety management. The diagnostic radiation system will also assure competitive power through a conforming evaluation unifying the differing standards, technical specifications, and recognized processes.