An analytical method for determining the scope of checks for the reliability of medical devices using parametric models

The presented materials set out the main provisions for setting reliability requirements, methods for assessing reliability indicators at the stages of development and testing, taking into account the design and functioning of medical devices and their classification, methods of using a priori information about the reliability of analogue products. The use of methods based on functional reliability models in reliability assessments and the involvement of additional information about the values of product parameters recorded during the checks allows reducing the amount of checks required to confirm the specified reliability requirements. The work also shows that the currently existing methodological materials do not consider the issues of assessing the entire range of reliability indicators presented to the products being developed.