Multi-parameter fuzzy design space for QbD approach applied in the development of biomedical devices

Since 2004, on the recommendation of the Food and Drug Administration (FDA), the concept of Quality by Design (QbD) has been widely applied by the pharmaceutical industry in drug development. The paradigm for quality assurance has been changed from inspections tests to focusing on increasing control within manufacturing processes. Recently, the methodology of QbD has gained space in the area of development of transducers for biomedical application. In order to advance on the adoption of this approach to the characteristics and needs of this new field, a methodology of representation of a multiparameter Design Space with fuzzy inference was developed.