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Information × Registration Number 0223U004515, 0122U200930 , R & D reports Title Improvement of qualitative methods of risk assessment in ensuring the quality of medical products popup.stage_title Head Trishch Roman M., д.т.н. Registration Date 14-11-2023 Organization Ukrainian Engineering Pedagogics Academy popup.description2  The purpose of the study is to propose qualimetric methods for assessing the risks of medical devices and to develop methods for their assessment at different stages of the full production cycle, taking into account the requirements of international standards. The object of research is the process of risk assessment in the design, manufacture and maintenance of medical devices. The subject of the study is methods, algorithms and techniques for quantitative assessment of the quality of medical devices, taking into account their features as an object of qualimetry. Scientific novelty of the results. The following scientific results were obtained as a result of the research: 1. For the first time, using algebraic transformations and elements of mathematical statistics, the density function of distribution of functionally dependent estimates of quality indicators of medical devices was determined, provided that the normal distribution law and knowledge of the estimates of parameters of single quality indicators, which allows to determine the probability of their belonging to a given evaluation interval. 2. For the first time, knowing the density function of the distribution of functionally dependent estimates of quality indicators of medical devices and applying the method of integration, the probabilities of belonging of dimensionless estimates of quality indicators to a given evaluation interval are obtained, which will allow determining the risks of obtaining products of unsatisfactory quality. 3. Using the method of moments and Pearson curves, it is proved that the distribution of random variables of the uptime of medical devices (neodymium lasers) and the failure rate of their elements (manipulator lamps) corresponds to the exponential distribution law and the Weibull-Gnedenko distribution law, respectively, which will allow determining the probability of the risk of an adverse situation (failure). Product Description popup.authors Artyukh Svitlana Bahaev Ihor Hrinchenko Volodymyr Hanna S. Hrinchenko Kiporenko Oleksii Nataliia Sorokolat Trishch Yuliia Fateeva Lina Olena Chernyak popup.nrat_date 2023-11-14 Close