ResourceClinical Diagnostics
Quality considerations for a successful diagnostic assay launch
25 Apr 2023The increasing prevalence of infectious disease has heightened demand for an in vitro diagnostics (IVD) that is low complexity, portable, rapid, and inexpensive to manufacture. In this application note, learn how safe and effective product development of IVD's are achieved through proper control of the product design, methods for planning the production process, and adequate risk management strategies throughout the product lifecycle.