Quality considerations for a successful diagnostic assay launch

26 April 2023

The 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.