White Paper: Quality Considerations for a Successful Diagnostic Assay Launch

The increase in infectious disease prevalence has led to a heightened demand for in-vitro diagnostics that have low complexity, are portable, rapid, and inexpensive to manufacture. Lateral flow assays (LFAs) have addressed this demand in the recent past during the Covid-19 pandemic.

Developing an IVD lateral flow assay takes a large amount of capital investment, as result of which companies often rush through product development to reduce costs and expedite the time to market to begin recovering their investments.

In this white paper we talk about the benefits of taking the time to build quality into the product development workflow, and highlight the importance of design controls to streamline product development, and ensure:

The device/assay meets user needs and intended use
Issues with product quality and consistency are avoided
A safe and effective product is developed

White Paper: Quality Considerations for a Successful Diagnostic Assay Launch

The increase in infectious disease prevalence has led to a heightened demand for in-vitro diagnostics that have low complexity, are portable, rapid, and inexpensive to manufacture. Lateral flow assays (LFAs) have addressed this demand in the recent past during the Covid-19 pandemic.

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