This work presents the adaptation of the Quality by Design (QbD) approach aiming to apply it to the quality assurance of a measurement system for clinical use for locating non-ferromagnetic metallic foreign objects inserted in the human body. The Target Product Profile (TPP) was identified in association with the functionalities of the system, complying with biometrological precepts such as: metrological performance, low manufacturing and operating costs, low complexity, portability and safety. The Critical Quality Attributes (CQAs) of the system were determined, which must be controlled throughout its development to guarantee its quality. Critical Process Parameters (CPPs) and their acceptable ranges of variation were identified. A risk analysis was previous performed between CQAs and CPPs, determining those with a higher dependency ratio, in order to establish the appropriate combinations to construct the Design Space (DS). Due to the characteristics of the data obtained in the first stages of the implementation of QbD, fuzzy inference was used between CPPs and CQAs with high dependence. The results obtained with the DS configuration enabled the determination of the acceptable operating ranges of the CPPs, which ensure the adequacy of the metrological aspects of the biomedical equipment under development, contributing to the reliability of its diagnostic and therapeutic application.