OPTIMIZATION OF THE CONFORMITY ASSESSMENT PROCESS FOR MEDICAL DEVICES UNDER CONDITIONS ENSURING THE EVALUATION OF SAFETY AND PERFORMANCE PARAMETERS
DOI:
https://doi.org/10.52326/jes.utm.2026.33(2).05Keywords:
medical devices, periodic conformity assessment, periodic inspection, non-destructive testing, standards, safety, performance, reliability, efficiency, qualityAbstract
Periodic verification through examinations and laboratory testing represents a technical operation that can ensure an adequate level of performance and safety of medical devices. This verification ensures the assessment of general safety, electrical safety, functionality, alarm control, and, most importantly, the performance parameters of medical devices. In order to establish a service system intended for the periodic conformity assessment of medical devices, it was necessary to identify new methodological approaches. This methodology is based on the cost–effectiveness ratio, ensuring the application of a minimum set of non-destructive methods in accordance with standards, while guaranteeing an appropriate level of performance and safety of medical devices.
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